FDA product code LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
LXT is the FDA product code for appliance, fixation, nail/blade/plate combination, multiple component, metal composite. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 57 510(k) submissions under LXT, 1 in the last five years, from 27 different applicants. The average 510(k) review took 73 days (median 63). FDA has posted 14 recalls for LXT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LXT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 256 |
Compare with all 510(k) review times · Search every LXT clearance
Top LXT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 14 | 2008-01-29 |
| Howmedica Osteonics Corp. | 8 | 2005-06-17 |
| Immedica, Inc. | 5 | 2000-12-15 |
| Hand Innovations, LLC | 3 | 2006-04-28 |
| Hand Innovations, Inc. | 3 | 2005-04-26 |
22 more applicants have LXT clearances. See the full list in Caduvo.
Most recent LXT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230067 | New Paradigm Biomedical | Para-Fix External Fixation System | 2023-09-22 | 256 |
| K131636 | Acumed, LLC | POLARUS CONNECT | 2013-10-10 | 128 |
| K132704 | Biomet | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | 2013-10-09 | 41 |
| K112345 | Medos International SARL | DISTAL VOLAR RADIUS PLATING SYSTEMS | 2011-10-31 | 77 |
| K090374 | DePuy Orthopaedics, Inc. | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | 2009-03-11 | 22 |
Recalls for LXT devices
14 product recalls in 7 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-06-02.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code LXT?
LXT is the FDA product code for appliance, fixation, nail/blade/plate combination, multiple component, metal composite. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is LXT?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXT?
Across 57 cleared submissions the average was 73 days from receipt to decision (median 63).
Which companies have the most LXT clearances?
Synthes (Usa) (14); Howmedica Osteonics Corp. (8); Immedica, Inc. (5); Hand Innovations, LLC (3); Hand Innovations, Inc. (3).
Have LXT devices been recalled?
Yes: 14 product recalls across 7 recall events; the most recent began 2022-06-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LXT
- Run a recall and safety report across every LXT manufacturer
- Watch product code LXT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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