← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K961589 # APR FULLY TEXTURED HIP STEM (K961589) _Intermedics Orthopedics · LZO · Jul 9, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K961589 ## Device Facts - **Applicant:** Intermedics Orthopedics - **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md) - **Decision Date:** Jul 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. ## Device Story Nonporous, anatomic femoral component for hip arthroplasty; replaces proximal femur. Manufactured from Ti-6Al-4V alloy; features full-length surface texturing for cemented or press-fit fixation. Design includes anterior angulation, double-wedge proximal body, 12/14 Morse taper for modular heads, and circular distal cross-section. Larger sizes include distal cylindrical hole for increased flexibility. Used by orthopedic surgeons in clinical/OR settings. Provides stable femoral fixation; facilitates joint reconstruction; restores hip function. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Wrought Ti-6Al-4V alloy (ASTM F 136). Design: Nonporous, anatomic femoral stem with full-length surface texturing. Features: 12/14 Morse taper, anterior angulation, double-wedge proximal body, circular distal cross-section, distal cylindrical hole for flexibility. Configuration: Left and right versions in multiple sizes. 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 - Bi-Metric Primary Interlok Hip Stem (Biomet, Inc.) - Alloclassic Zweymüller Cementless Stem (Sulzer Orthopedics, AG) ## 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} JUL 9 1996 K961589 510(k) SUMMARY In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. APR® Fully Textured Hip Stem. Submitter: Intermedics Orthopedics, Inc. 9900 Spectrum Drive Austin, TX 78717 (512) 432-9687 Date: April 23, 1996 Contact Person: Jacquelyn Hughes Manager, Regulatory Affairs Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21CFR 888.3353 Common/Usual Name: Femoral Component Trade/Proprietary: APR® Fully Textured Hip Stem Product Description/Substantial Equivalence: The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is a nonporous, anatomic femoral component that comes in a variety of sizes in both left and right configurations. This stem is manufactured from wrought Ti-6Al-4V alloy (ASTM F 136) and features surface texturing along the full length of the stem (with the exception of the neck area) for enhanced fixation in cemented or press-fit applications. In addition, the APR® Fully Textured Hip Stem: - incorporates an anterior angulation in the proximal body to match the normal anterior angulation of the natural femur; - features a double wedge shaped proximal body to maximize filling of the proximal femur; - has a 12/14 Morse taper making it compatible with modular femoral heads; - has a distal stem with a circular cross section allowing for ease in canal preparation and prosthesis insertion; and; - incorporates a cylindrical hole in the distal stem of the larger sizes to increase distal stem flexibility. The APR® Fully Textured Hip Stem is substantially equivalent to the Bi-Metric Primary Interlok Hip Stem (Biomet, Inc.) and the Alloclassic Zweymüller Cementless Stem (Sulzer Orthopedics, AG). 00022 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K961589](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K961589) **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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