Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4540](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4540) → LXH — Orthopedic Manual Surgical Instrument # LXH · Orthopedic Manual Surgical Instrument _Orthopedic · 21 CFR 888.4540 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH ## Overview - **Product Code:** LXH - **Device Name:** Orthopedic Manual Surgical Instrument - **Regulation:** [21 CFR 888.4540](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4540) - **Device Class:** 1 - **Review Panel:** [Orthopedic](/submissions/OR) ## Identification An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. ## Recent Cleared Devices (20 of 58) Showing 20 most recent of 58 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K192873](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K192873.md) | SX-One MicroKnife | Sonex Health, Inc. | Dec 20, 2019 | SESE | | [K140414](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K140414.md) | IMBIBE NEEDLE | Orthovita, Inc. | Apr 1, 2014 | SESE | | [K101609](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K101609.md) | SELF RETAINING SOFT TISSUE RETRACTOR | Koros USA, Inc. | Dec 9, 2010 | SESE | | [K001507](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K001507.md) | MICROPERFORATION INSTRUMENT | Smith & Nephew, Inc. | Jun 14, 2000 | SESE | | [K952495](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K952495.md) | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Orthopedic Systems, Inc. | Jan 22, 1996 | SESE | | [K943873](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K943873.md) | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Orthomet, Inc. | Apr 26, 1995 | SESE | | [K944188](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K944188.md) | SPINAL MARKER | Leibinger L.P. | Apr 13, 1995 | SESE | | [K941896](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K941896.md) | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR | Depuy, Inc. | Nov 7, 1994 | SESE | | [K941711](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K941711.md) | HYPERFLEX FLEXIBLE GUIDEWIRES | Linvatec Corp. | Aug 26, 1994 | SESE | | [K941605](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K941605.md) | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH | Stryker Corp. | Aug 5, 1994 | SESE | | [K933772](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K933772.md) | PUNCH SURGICAL | Mahe-Medizintechnik | Feb 1, 1994 | SESE | | [K933242](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K933242.md) | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Danek Medical, Inc. | Jan 28, 1994 | SESE | | [K934260](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K934260.md) | BARRIER BONE WAX APPLICATOR | Phillips Pharmaceuticals, Inc. | Jan 26, 1994 | SESE | | [K931846](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K931846.md) | BIO-PREP | Biomedical Devices, Inc. | Jan 21, 1994 | SESE | | [K930028](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K930028.md) | CALMPS: BONE, MASTIN, LEWIN, BRAND | Thomasville Medical Assoc. | Feb 16, 1993 | SESE | | [K921402](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K921402.md) | SURGICAL INSTRUMENT, DISPOSABLE | Macro Medical, Inc. | Jun 4, 1992 | SESE | | [K921645](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K921645.md) | AMSEN SPINE IMPACTOR INSTRUMENTS | Advanced Med/Surg, Inc. | Jun 3, 1992 | SESE | | [K921644](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K921644.md) | AMSEN HOCKEY STICK CHISEL | Advanced Med/Surg, Inc. | Jun 3, 1992 | SESE | | [K921643](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K921643.md) | AMSEN POSTERIOR DISC EVACUATOR | Advanced Med/Surg, Inc. | Jun 3, 1992 | SESE | | [K921642](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH/K921642.md) | AMSEN DOUBLE-ENDED FORAMINAL PROBE | Advanced Med/Surg, Inc. | Jun 3, 1992 | SESE | ## Top Applicants - Dhason Brothers, Inc. — 10 clearances - Advanced Med/Surg, Inc. — 4 clearances - Mumtaz I. Malik — 4 clearances - Onyx Medical Corp. — 3 clearances - Acufex Microsurgical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com