FDA product code LYT: Fixation Accessory
LYT is the FDA product code for fixation accessory. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 9 510(k) submissions under LYT, from 7 different applicants. The average 510(k) review took 67 days (median 65). FDA has posted 4 recalls for LYT devices.
Classification
| Field | Value |
|---|---|
| Device name | Fixation Accessory |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LYT clearance
Top LYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Westcon Orthopedics, Inc. | 3 | 1992-01-09 |
| The Jerome Group, Inc. | 1 | 2004-04-12 |
| Chapel and Assoc. | 1 | 1998-12-04 |
| Osteonics Corp. | 1 | 1998-05-05 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 1990-09-14 |
2 more applicants have LYT clearances. See the full list in Caduvo.
Most recent LYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040363 | The Jerome Group, Inc. | CERAMIC TIPPED SKULL PIN | 2004-04-12 | 59 |
| K983685 | Chapel and Assoc. | BONE BAND | 1998-12-04 | 45 |
| K980594 | Osteonics Corp. | OSTEONICS FX-CABLELOK GRIP COMPONENTS | 1998-05-05 | 77 |
| K914812 | Westcon Orthopedics, Inc. | K-CAP-E, STERILE | 1992-01-09 | 76 |
| K912762 | Westcon Orthopedics, Inc. | K-CAP-I, STERILE | 1991-07-18 | 24 |
Recalls for LYT devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-21.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LYT?
LYT is the FDA product code for fixation accessory. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is LYT?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYT?
Across 9 cleared submissions the average was 67 days from receipt to decision (median 65).
Which companies have the most LYT clearances?
Westcon Orthopedics, Inc. (3); The Jerome Group, Inc. (1); Chapel and Assoc. (1); Osteonics Corp. (1); Micro-Aire Surgical Instruments, Inc. (1).
Have LYT devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2018-06-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LYT
- Run a recall and safety report across every LYT manufacturer
- Watch product code LYT 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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