K261049 · official summary PDF ↗
No reviewed topic index available; open the original document.
FDA record research
Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) — FDA decisions, comparisons and evidence
The 2021–2025 analysis contains 191 selected substantially-equivalent FDA decisions under primary product code MAX. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 17 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-08-20. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 191 decisions; the separate all-observed-date count is 896. These denominators describe different date ranges.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Historical FDA comparison
2021–2025: five complete calendar years
All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.
191Selected decisions in these five years
94.0Median receipt-to-decision calendar days
191Valid date pairs in the distribution
The middle 50% of the 191 valid date pairs spans 56.5–160.0 calendar days. This describes selected recorded submissions, including elapsed time outside active FDA review. It is not an FDA review-time measure or a delivery promise.
202153
202241
202330
202438
202529
Compare like submission types
| Recorded type | Decisions | Valid date pairs | Median calendar days | Middle 50% |
|---|---|---|---|---|
| Special | 38 | 38 | 30.0 | 28.0–57.8 |
| Traditional | 153 | 153 | 111.0 | 70.0–171.0 |
Different submission types and evidence packages are not interchangeable. These selected records do not establish that a particular route is available for your product.
Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).
Filters, exclusions and reproducible calculation
Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.
896 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.
Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.
Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.
Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.
Separate partial-year update
2026 decisions through 2026-09-27
17 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 25 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
Latest decisions across the database
These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.
| Official record / device | Recorded applicant | Decision | Recorded type | Calendar days |
|---|---|---|---|---|
| K261049 ↗SCALA® TL | Spineart SA | 2026-08-20 | Traditional | 142 |
| K261430 ↗TruLift Expandable System | Life Spine, Inc. | 2026-07-28 | Traditional | 89 |
| K253011 ↗Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 | Traditional | 301 |
| K261020 ↗Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 | Traditional | 109 |
| K253420 ↗Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | 2026-07-01 | Traditional | 273 |
| K253151 ↗Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 | Traditional | 262 |
| K261159 ↗Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 | Traditional | 51 |
| K253894 ↗BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026-05-28 | Traditional | 175 |
Supporting documents actually acquired
Go beyond the database row
Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.
K261430 · official summary PDF ↗
No reviewed topic index available; open the original document.
K253011 · official summary PDF ↗
- Term mention: Sterilization · PDF page 6 Term occurrence only; read the original passage, including limitations and negation.
The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.
Recorded classification context
Known context: US. Match the intended use and design with the recorded category before treating it as applicable.
| Source fact | Recorded value |
|---|---|
| FDA product code | MAX [1] |
| Generic device category | Intervertebral Fusion Device With Bone Graft, Lumbar [1] |
| Recorded scope | Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft. [1] |
| Recorded class | 2 [1] |
| Regulation | 888.3080 [1] |
| Medical specialty | Orthopedic [1] |
Build a comparison that explains the differences
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Compare your intended use with a named decision
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
Explain the technology and evidence differences
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
Make the estimate comparable
Use the 2021–2025 cohort, and compare the recorded submission type before discussing calendar elapsed time. Separate your own preparation work from the recorded receipt-to-decision period.
Useful evidence: Chosen K numbers, submission types, dates and your own document/test readiness.
Work packages and dependencies
- Conditional: FDA 510(k) Submission Services — Review the supplied facts and evidence gaps before confirming the service scope.
- Optional: Find FDA US Agent Services | Compare & Get Quotes — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
- Optional: FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment) — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
What needs to happen first
- FDA 510(k) Submission Services → Find FDA US Agent Services | Compare & Get Quotes: Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
- FDA 510(k) Submission Services → FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment): Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
Questions for providers
- Which of the named MAX decisions are actually comparable to our proposed indications and technology, and which would you exclude?
- Which evidence differences prevent us from using the comparison yet, and what deliverable resolves each one?
- Does your schedule separate submission preparation, testing, FDA interactions and customer response time? What assumptions change it?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
FDA openFDA — device classification records ↗
2026-10-05 · retrieved 2026-10-06
Audit details: precise locators and snapshot identifiers
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
- [1] device-classification-0001-of-0001.json:results[2941] · record 1d5fbabb7f52e6f96b2331f033a6098869078fed58a35e69899a9ce10d6867ab
FDA openFDA — 510(k) decision dataset (bulk partition) ↗
2026-10-05 · retrieved 2026-10-06
Audit details: precise locators and snapshot identifiers
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
- [2] Complete results array; fda-buyer-window:MAX · record whole dataset partition
FDA 510(k) summary — K253011 ↗
Fri, 07 Aug 2026 21:30:35 GMT · retrieved 2026-10-07
Audit details: precise locators and snapshot identifiers
Source key D02 · snapshot a2d94e898dc1aeea7146e79be42ba39b7f95116daa320f2a5d2b1109ff400d3c
- [3] PDF page 6 · record f7120bae01e1e38f509e81e61cf9637da249e04568fadea30029d7cd6591ea2a
Prepare an editable project brief
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
Compare FDA 510(k) Submission Services
Find FDA US Agent Services | Compare & Get Quotes · FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)