Who is the manufacturer of APR FULLY TEXTURED HIP STEM?

Intermedics Orthopedics submitted the Traditional clearance for APR FULLY TEXTURED HIP STEM (K961589).

What is the FDA product code for APR FULLY TEXTURED HIP STEM?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for APR FULLY TEXTURED HIP STEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for APR FULLY TEXTURED HIP STEM?

Bi-Metric Primary Interlok Hip Stem (Biomet, Inc.); Alloclassic Zweymüller Cementless Stem (Sulzer Orthopedics, AG).

APR FULLY TEXTURED HIP STEM

K961589 · Intermedics Orthopedics · LZO · Jul 9, 1996 · Orthopedic

Device Facts

Record ID	K961589
Device Name	APR FULLY TEXTURED HIP STEM
Applicant	Intermedics Orthopedics
Product Code	LZO · Orthopedic
Decision Date	Jul 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
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).

Indications for Use

Indicated for patients requiring prosthetic replacement of the proximal femur during hip replacement surgery.

Regulatory Classification

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)

Related Devices

K964769 — VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS · Zimmer, Inc. · Feb 13, 1997
K041109 — ZIMMER ANATOMIC II HIP PROSTHESIS · Zimmer, Inc. · Jul 20, 2004
K974294 — ENCORE LINEAR POROUS COATED HIP · Encore Orthopedics, Inc. · Jan 12, 1998
K061786 — VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS · Zimmer, Inc. · Jul 24, 2006
K974331 — UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM · Johnson & Johnson Professionals, Inc. · Feb 6, 1998

Submission Summary (Full Text)

{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