FDA product code LZJ: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
LZJ is the FDA product code for prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained. It is a Unclassified device, reviewed by the Orthopedic panel. FDA has cleared 11 510(k) submissions under LZJ, from 9 different applicants. The average 510(k) review took 246 days (median 201). FDA has posted 1 recall for LZJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained |
| Device class | Unclassified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LZJ clearance
Top LZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acu Med, Inc. | 2 | 1995-07-31 |
| Biomet, Inc. | 2 | 1994-12-19 |
| Arthrosurface, Inc. | 1 | 2014-02-26 |
| Ascension Orthopedics, Inc. | 1 | 2010-12-21 |
| Merete Medical GmbH | 1 | 2008-05-08 |
4 more applicants have LZJ clearances. See the full list in Caduvo.
Most recent LZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132496 | Arthrosurface, Inc. | ARTHROSURFACE TOEMOTION | 2014-02-26 | 201 |
| K102549 | Ascension Orthopedics, Inc. | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | 2010-12-21 | 105 |
| K072251 | Merete Medical GmbH | MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM | 2008-05-08 | 269 |
| K950864 | Acu Med, Inc. | GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) | 1995-07-31 | 154 |
| K941650 | Biomet, Inc. | TOTAL TOE SYSTEM II | 1994-12-19 | 258 |
Recalls for LZJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-09.
Frequently asked questions
What is FDA product code LZJ?
LZJ is the FDA product code for prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained. It is a Unclassified device, reviewed by the Orthopedic panel.
What device class is LZJ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZJ?
Across 11 cleared submissions the average was 246 days from receipt to decision (median 201).
Which companies have the most LZJ clearances?
Acu Med, Inc. (2); Biomet, Inc. (2); Arthrosurface, Inc. (1); Ascension Orthopedics, Inc. (1); Merete Medical GmbH (1).
Have LZJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LZJ
- Run a recall and safety report across every LZJ manufacturer
- Watch product code LZJ 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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