Cruxi
FDA record research
The 2021–2025 analysis contains 21 selected substantially-equivalent FDA decisions under primary product code PBF. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 1 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-03-27. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 21 decisions; the separate all-observed-date count is 27. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories. (a) Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. (b) Classification. Class II.
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Historical FDA comparison
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.
The middle 50% of the 21 valid date pairs spans 90.0–314.0 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.
| Recorded type | Decisions | Valid date pairs | Median calendar days | Middle 50% |
|---|---|---|---|---|
| Special | 2 | 2 | Withheld: n < 20 | — |
| Traditional | 19 | 19 | Withheld: n < 20 | — |
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).
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.
27 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
1 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 3 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
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 |
|---|---|---|---|---|
| K252064 ↗MedCAD® AccuStride System | Medcad | 2026-03-27 | Traditional | 269 |
| K250711 ↗VSP Orthopedics System | 3D Systems, Inc. | 2025-12-05 | Traditional | 270 |
| K242603 ↗MyPAO SA guides | Medacta International S.A. | 2025-11-19 | Traditional | 446 |
| K251709 ↗MedCAD® AccuStride System | Medcad | 2025-11-04 | Traditional | 154 |
| K250394 ↗Fine TTO | Bodycad Laboratories, Inc. | 2025-10-21 | Traditional | 251 |
| K250767 ↗Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-10-01 | Traditional | 202 |
| K250921 ↗CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025-06-25 | Traditional | 90 |
| K241811 ↗MedCAD® AccuStride System | Medcad | 2025-03-13 | Traditional | 265 |
Supporting documents actually acquired
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.
No reviewed topic index available; open the original document.
The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.
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 | PBF [1] |
| Generic device category | Orthopaedic Surgical Planning And Instrument Guides [1] |
| Recorded scope | As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures. [1] |
| Recorded class | 2 [1] |
| Regulation | 888.3030 [1] |
| Medical specialty | Orthopedic [1] |
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.
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
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.
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.
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.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
Tue, 07 Apr 2026 11:02:19 GMT · retrieved 2026-10-06
Source key D02 · snapshot 90315a78261599e7ebeccd5e3d8e8bfc23896df25b611eba7e500af98970757e
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Fri, 05 Dec 2025 20:48:07 GMT · retrieved 2026-10-07
Source key D02 · snapshot d2e054feac30b9a3681de4c02ca698e063f7b00c5bcd5321d2ba5d6bfc6f0f0c
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
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)