← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K970200 # RELIANCE PF FEMORAL STEMS (K970200) _Howmedica Corp. · LZO · Apr 9, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K970200 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md) - **Decision Date:** Apr 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement. ## Device Story Reliance® PF Femoral Stem; metallic hip prosthesis component. Used for primary/secondary proximal femur reconstruction. Operates via press-fit mechanical interlock or bone cement fixation. Used in conjunction with V40 femoral heads, acetabular components, and unipolar/bipolar components. Physician-operated in surgical setting. Provides structural replacement for damaged hip joint; restores joint function. ## Clinical Evidence Bench testing only. Endurance load testing demonstrated performance exceeding the Semlitsch minimum of 630 lbs. ## Technological Characteristics Material: Forged cobalt-chromium-molybdenum (Vitallium®) alloy. Design: Femoral stem for total hip arthroplasty. Fixation: Press-fit (mechanical interlock) or cemented. Energy source: None (mechanical). ## Regulatory Identification A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement. ## Predicate Devices - HNR Hip System ([K903563](/device/K903563.md)) - DRG Femoral component ([K936126](/device/K936126.md)) - Premium Femoral Component ([K936127](/device/K936127.md)) - McCutchen Hip System (Dow Corning Wright) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} APR - 9 1997 510(k) Summary K970200 Proprietary Name: Reliance® PF Femoral Stems Common Name: Metallic Hip Stem Classification Name and Reference: 21 CFR 888.3353 Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis. Proposed Regulatory Class: Class II Device Product Code: LZO For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 1-17-97 The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement. The Reliance® PF stem is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy. The substantial equivalence of the Reliance® PF stem is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's HNR Hip System (K903563), DRG Femoral component (K936126), Premium Femoral Component (K936127), and Dow Corning Wright's McCutchen Hip System. Testing has demonstrated that the endurance load exceeds the Semlitsch minimum of 630 lbs. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K970200](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K970200) **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. 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