FDA product code LXH: Orthopedic Manual Surgical Instrument
LXH is the FDA product code for orthopedic manual surgical instrument. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 58 510(k) submissions under LXH, from 36 different applicants. The average 510(k) review took 92 days (median 58). FDA has posted 526 recalls for LXH devices, 39 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LXH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 73 |
Compare with all 510(k) review times · Search every LXH clearance
Top LXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dhason Brothers, Inc. | 10 | 1989-02-13 |
| Advanced Med/Surg, Inc. | 4 | 1992-06-03 |
| Mumtaz I. Malik | 4 | 1990-09-28 |
| Onyx Medical Corp. | 3 | 1990-07-30 |
| Orthopedic Systems, Inc. | 2 | 1996-01-22 |
31 more applicants have LXH clearances. See the full list in Caduvo.
Most recent LXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192873 | Sonex Health, Inc. | SX-One MicroKnife | 2019-12-20 | 73 |
| K140414 | Orthovita, Inc. | IMBIBE NEEDLE | 2014-04-01 | 42 |
| K101609 | Koros USA, Inc. | SELF RETAINING SOFT TISSUE RETRACTOR | 2010-12-09 | 184 |
| K001507 | Smith & Nephew, Inc. | MICROPERFORATION INSTRUMENT | 2000-06-14 | 30 |
| K952495 | Orthopedic Systems, Inc. | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | 1996-01-22 | 237 |
Recalls for LXH devices
526 product recalls in 267 recall events; 39 initiated in the last five years and 40 still open. Most recent: 2026-07-01.
| Year | Recalls |
|---|---|
| 2017 | 29 |
| 2018 | 39 |
| 2019 | 23 |
| 2020 | 16 |
| 2021 | 7 |
| 2022 | 7 |
| 2023 | 10 |
| 2024 | 8 |
| 2025 | 4 |
| 2026 | 8 |
Frequently asked questions
What is FDA product code LXH?
LXH is the FDA product code for orthopedic manual surgical instrument. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is LXH?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LXH?
Across 58 cleared submissions the average was 92 days from receipt to decision (median 58).
Which companies have the most LXH clearances?
Dhason Brothers, Inc. (10); Advanced Med/Surg, Inc. (4); Mumtaz I. Malik (4); Onyx Medical Corp. (3); Orthopedic Systems, Inc. (2).
Have LXH devices been recalled?
Yes: 526 product recalls across 267 recall events; the most recent began 2026-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LXH
- Run a recall and safety report across every LXH manufacturer
- Watch product code LXH 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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