Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3330](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3330) → KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) # KWA · Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) _Orthopedic · 21 CFR 888.3330 · Class 3_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA ## Overview - **Product Code:** KWA - **Device Name:** Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - **Regulation:** [21 CFR 888.3330](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3330) - **Device Class:** 3 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). ## Classification Rationale Class III. ## Recent Cleared Devices (20 of 114) Showing 20 most recent of 114 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K122778](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K122778.md) | PROFEMUR Z REVISION HIP STEM | Wrightmedicaltechnologyinc | Oct 11, 2012 | SESE | | [K121544](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K121544.md) | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | Jul 30, 2012 | SESE | | [K113271](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K113271.md) | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | Biomet Manufacturing, Inc. | May 18, 2012 | SESE | | [K113322](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K113322.md) | CONSERVE THIN SHELL | Wrightmedicaltechnologyinc | Feb 3, 2012 | SESE | | [K112080](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K112080.md) | PRESERVE HIP STEM | Wrightmedicaltechnologyinc | Dec 28, 2011 | SESE | | [K112150](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K112150.md) | PROFEMUR GLADIATOR HA HIP STEM | Wrightmedicaltechnologyinc | Nov 23, 2011 | SESE | | [K113019](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K113019.md) | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | Nov 10, 2011 | SESE | | [K111910](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K111910.md) | GLADIATOR HIP STEM | Wrightmedicaltechnologyinc | Oct 14, 2011 | SESE | | [K110836](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K110836.md) | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | Zimmer GmbH | Oct 7, 2011 | SESE | | [K110400](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K110400.md) | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | Sep 30, 2011 | SESE | | [K111699](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K111699.md) | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | Wrightmedicaltechnologyinc | Aug 19, 2011 | SESE | | [K111698](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K111698.md) | PROFEMUR(R) E CEMENTLESS HIP STEM | Wrightmedicaltechnologyinc | Aug 19, 2011 | SESE | | [K110399](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K110399.md) | GLADIATOR PLASMA CLASSIC HIP STEM | Wrightmedicaltechnologyinc | May 10, 2011 | SESE | | [K110029](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K110029.md) | CONSERVE BIO FOAM SHELL | Wrightmedicaltechnologyinc | Apr 19, 2011 | SESE | | [K103755](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K103755.md) | TAPERLOC COMPLETE, SIZE 5 AND 6 | Biomet Manufacturing Corp | Jan 21, 2011 | SESE | | [K102565](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K102565.md) | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS | Wrightmedicaltechnologyinc | Dec 22, 2010 | SESE | | [K100469](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K100469.md) | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | Dec 7, 2010 | SESE | | [K101086](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K101086.md) | TAPERLOC COMPLETE | Biomet, Inc. | Sep 3, 2010 | SESE | | [K101475](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K101475.md) | COMPRESS ANTI-ROTATION SPINDLES | Biomet Manufacturing Corp | Jun 18, 2010 | SESE | | [K093235](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K093235.md) | RINGLOC + HYBRID ACETABULAR SYSTEM | Biomet, Inc. | Apr 30, 2010 | SESE | ## Top Applicants - Wrightmedicaltechnologyinc — 26 clearances - Biomet Manufacturing Corp — 13 clearances - DePuy Orthopaedics, Inc. — 12 clearances - Biomet, Inc. — 11 clearances - Zimmer GmbH — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA) **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