LXHFDA Class 1 · 21 CFR 888.4540
Orthopedic Manual Surgical Instrument
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
58
Manufacturers
17
Flagged signals
13
Adverse-event reports
71,933
Code matrix
| FDA product code | LXH |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2013 | 3 | 498.8 | 1,036 |
| Other | 2015 | 3 | 498.8 | 1,036 |
| Death | 2022 | 3 | 113.5 | 234 |
| Other | 2010 | 7 | 43.5 | 250 |
| Other | 2010 | 13 | 26.9 | 300 |
| Other | 2011 | 3 | 18.6 | 34 |
| Other | 2009 | 3 | 6.2 | 8 |
| Other | 2014 | 8 | 5.6 | 26 |
| Other | 2013 | 7 | 4.9 | 18 |
| Other | 2010 | 5 | 4.3 | 10 |
| Injury | 2020 | 8 | 2.6 | 10 |
| Injury | 2022 | 5 | 2.6 | 6 |
| Injury | 2013 | 8 | 2.3 | 8 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 1 family · 71,933 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Onyx Medical Corp. | 3 | 1990 | — |
| Stryker Corp. | 2 | 1994 | — |
| Orthopedic Systems, Inc. | 2 | 1996 | — |
| Acufex Microsurgical, Inc. | 2 | 1984 | — |
| Danek Medical, Inc. | 1 | 1994 | — |
| Orthomet, Inc. | 1 | 1995 | — |
| Dow Corning Wright | 1 | 1980 | — |
| Buckman Co., Inc. | 1 | 1986 | — |
| Concept, Inc. | 1 | 1988 | — |
| Smith & Nephew, Inc. | 1 | 2000 | — |
| Howmedica Corp. | 1 | 1981 | — |
| Linvatec Corp. | 1 | 1994 | — |
| Richard'S Medical Equip., Inc. | 1 | 1981 | — |
| Depuy, Inc. | 1 | 1994 | — |
| SONEX HEALTH, INC. | 1 | 2019 | — |
| W. L. Gore & Associates, Inc. | 1 | 1988 | — |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 1 | 1980 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
SX-One MicroKnife · Sonex Health, Inc.510(k) · 2019-12-20
IMBIBE NEEDLE · Orthovita, Inc.510(k) · 2014-04-01
SELF RETAINING SOFT TISSUE RETRACTOR · Koros USA, Inc.510(k) · 2010-12-09
MICROPERFORATION INSTRUMENT · Smith & Nephew, Inc.510(k) · 2000-06-14
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM · Orthopedic Systems, Inc.510(k) · 1996-01-22
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY · Orthomet, Inc.510(k) · 1995-04-26
SPINAL MARKER · Leibinger L.P.510(k) · 1995-04-13
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR · Depuy, Inc.510(k) · 1994-11-07
HYPERFLEX FLEXIBLE GUIDEWIRES · Linvatec Corp.510(k) · 1994-08-26
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH · Stryker Corp.510(k) · 1994-08-05
PUNCH SURGICAL · Mahe-Medizintechnik510(k) · 1994-02-01
SOFAMOR ORTHOPAEDIC INSTRUMENTS · Danek Medical, Inc.510(k) · 1994-01-28
BARRIER BONE WAX APPLICATOR · Phillips Pharmaceuticals, Inc.510(k) · 1994-01-26
BIO-PREP · Biomedical Devices, Inc.510(k) · 1994-01-21
CALMPS: BONE, MASTIN, LEWIN, BRAND · Thomasville Medical Assoc.510(k) · 1993-02-16
SURGICAL INSTRUMENT, DISPOSABLE · Macro Medical, Inc.510(k) · 1992-06-04
AMSEN POSTERIOR DISC EVACUATOR · Advanced Med/Surg, Inc.510(k) · 1992-06-03
AMSEN DOUBLE-ENDED FORAMINAL PROBE · Advanced Med/Surg, Inc.510(k) · 1992-06-03
AMSEN SPINE IMPACTOR INSTRUMENTS · Advanced Med/Surg, Inc.510(k) · 1992-06-03
AMSEN HOCKEY STICK CHISEL · Advanced Med/Surg, Inc.510(k) · 1992-06-03
OSTEOTOMES OF VARIOUS TYPES · Mumtaz I. Malik510(k) · 1990-09-28
VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 · Mumtaz I. Malik510(k) · 1990-09-28
RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS · Mumtaz I. Malik510(k) · 1990-09-28
CHISEL, BONE, SURGICAL · Mumtaz I. Malik510(k) · 1990-09-28
LAMINECTOMY ROGEUR · Ruggles Corp.510(k) · 1990-08-09
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.