FDA product code LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LWJ is the FDA product code for prosthesis, hip, semi-constrained, metal/polymer, uncemented. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel. FDA has cleared 81 510(k) submissions under LWJ, from 37 different applicants. The average 510(k) review took 144 days (median 99). FDA has posted 26 recalls for LWJ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3360 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LWJ clearance
Top LWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plus Orthopedics | 7 | 2003-09-23 |
| Osteonics Corp. | 6 | 1998-10-21 |
| Stelkast Company | 5 | 2003-09-22 |
| Encore Orthopedics, Inc. | 4 | 2000-12-04 |
| Hayes Medical, Inc. | 3 | 2007-01-31 |
32 more applicants have LWJ clearances. See the full list in Caduvo.
Most recent LWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120595 | Consensus Orthopedics, Inc. | UNISYN PLUS HIP STEM | 2012-10-12 | 227 |
| K103518 | Corin USA | TRINITY ACETABULAR SYSTEM | 2011-03-09 | 99 |
| K090764 | Exactech, Inc. | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | 2009-04-21 | 29 |
| K082146 | Aesculap Implant Systems, Inc. | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | 2008-09-09 | 41 |
| K070061 | Hayes Medical, Inc. | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | 2007-01-31 | 26 |
Recalls for LWJ devices
26 product recalls in 12 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-12-01.
| Year | Recalls |
|---|---|
| 2020 | 3 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LWJ?
LWJ is the FDA product code for prosthesis, hip, semi-constrained, metal/polymer, uncemented. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel.
What device class is LWJ?
Class II, regulation 21 CFR 888.3360. Typical premarket route: 510(k).
How long does a 510(k) take for product code LWJ?
Across 81 cleared submissions the average was 144 days from receipt to decision (median 99).
Which companies have the most LWJ clearances?
Plus Orthopedics (7); Osteonics Corp. (6); Stelkast Company (5); Encore Orthopedics, Inc. (4); Hayes Medical, Inc. (3).
Have LWJ devices been recalled?
Yes: 26 product recalls across 12 recall events; the most recent began 2023-12-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LWJ
- Run a recall and safety report across every LWJ manufacturer
- Watch product code LWJ 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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