PRIMALOC CEMENTED HIP SYSTEM

K962448 · Ortho Development Corp. · KWY · Sep 19, 1996 · Orthopedic

Device Facts

• Record ID: K962448
• Device Name: PRIMALOC CEMENTED HIP SYSTEM
• Applicant: Ortho Development Corp.
• Product Code: KWY · Orthopedic
• Decision Date: Sep 19, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Primaloc™ Cemented Hip System is intended for single, cemented use during primary or revision arthroplasty surgery. Indications include: (1) Osteoarthritis or rheumatoid arthritis, or other osteoarthroses of the hip joint; (2) Certain femoral neck fractures; (3) Idiopathic avascular necrosis; (4) Post traumatic arthritis; (5) Benign or malignant bone tumors where sufficient bone stock is present to seat the prosthesis; (6) Previously failed implant.

Device Story

Primaloc™ Cemented Hip System; straight tapered femoral stem with conical collar; used in primary or revision hip arthroplasty. Input: surgical site anatomy; device provides structural replacement for femoral head/neck. Components: CoCr alloy stem (ASTM F799) with macro grooves and AlO2 blasted surface for cement fixation; PMMA cement spacer (ASTM F451) to prevent varus insertion; PMMA distal centralizer for canal alignment; UHMWPE cement restrictor (ASTM F648) for canal sealing. Operated by orthopedic surgeons in clinical/OR settings. Output: mechanical support for hip joint. Benefits: restoration of joint function and stability in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and geometric comparison to predicate devices.

Technological Characteristics

Materials: Cobalt-Chromium alloy (ASTM F799) stem; PMMA (ASTM F451) cement spacer and distal centralizer; UHMWPE (ASTM F648) cement restrictor. Design: Straight tapered stem, conical collar, macro-grooved proximal surface with AlO2 blast finish. Modular interface for CoCr femoral heads. Mechanical fixation via bone cement.

Indications for Use

Indicated for patients requiring primary or revision hip arthroplasty due to osteoarthritis, rheumatoid arthritis, other osteoarthroses, femoral neck fractures, idiopathic avascular necrosis, post-traumatic arthritis, benign/malignant bone tumors, or failed prior implants.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• Impact One-Piece Implant (Biomet)
• S-ROM OPC I Hip Stem for Cement (Joint Medical Products)
• Perfecta (Wright Medical)

Submission Summary (Full Text)

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ORTHO DEVELOPMENT

K962448

SEP 19 1996

Ortho Development Corporation

106 West 12200 South • Draper, Utah 84020

Phone [phone] • Fax [phone]

# Ortho Development Corporation 510(k) Summary

**Proprietary Name:** Primaloc™ Cemented Hip System

**Common Name:** Cemented hip prosthesis

**Classification Name:** Prosthesis, Hip, Hemi-/Metal/Polymer Cemented

**Regulatory Class:** Class II

## Intended Use

The Primaloc™ Cemented Hip System is intended for single, cemented use during primary or revision arthroplasty surgery. Indications include: (1) Osteoarthritis or rheumatoid arthritis, or other osteoarthroses of the hip joint; (2) Certain femoral neck fractures; (3) Idiopathic avascular necrosis; (4) Post traumatic arthritis; (5) Benign or malignant bone tumors where sufficient bone stock is present to seat the prosthesis; (6) Previously failed implant.

## System Description

The Primaloc™ Cemented Hip is a straight tapered stem with a conical type collar at the base of the neck. The stem is made of Cobalt-Chromium Alloy (CoCr, ASTM F799), and the proximal cone incorporates macro grooves and a rough $\mathrm{AlO}_2$ blasted surface for improved cement fixation. The femoral neck ends in a standard taper to interlock with Ortho Development Corporation Headloc™ CoCr modular femoral heads. A cement spacer, manufactured from PMMA, (polymethylmethacrylate, ASTM F451), is affixed to the proximal medial portion of the cone to help prevent varus insertion.

A distal centralizer, also made from PPMA, is affixed to the distal end of the femoral stem to align the stem within the medullary canal.

The Primaloc™ cement restrictor is manufactured from UHMWPE (ASTM F648). Prior to the introduction of bone cement into the medullary canal, the correctly sized cement restrictor is press-fit into the canal at a level below the final location of the implant. The cement restrictor incorporates annular grooves over its length to provide flexibility upon insertion.

## Substantial Equivalence:

The Primaloc™ Cemented Hip System is a combination of state-of-the-art features and geometry; however, since it is similar to other cemented total hip systems currently in commercial distribution in terms of intended use, geometry, features, and materials, it is expected that its safety and effectiveness will be also be equivalent. The FDA cleared, commercially available cemented stems substantially equivalent to the Primaloc™ Cemented Hip System include:

- Impact One-Piece Implant (Manufactured by Biomet)
- S-ROM OPC I Hip Stem for Cement (Manufactured by Joint Medical Products)
- Perfecta (Manufactured by Wright Medical, formerly Orthomet)

The Primaloc™ Cemented Hip System is substantially equivalent to the above-referenced hip systems for the following reasons: (1) the intended use for all referenced stems is identical to that of the Primaloc™ stem which is primary surgery in total hip arthroplasty (NINJD surgery or any of its composite diagnoses); (2) the referenced hip systems are all made from the same material, CoCr alloy, either cast of forged; (3) the dimensional characteristics regarding stem length and distal stem diameter are comparable; and (4) the referenced hip system geometry’s are similar to the Primaloc™ in terms of design and features. While there are slight variances between the Primaloc™ and these referenced hip systems, there is no significant difference which would affect safety or efficacy.

**Contact person:** Michelle M. Perry
Manager, Regulatory Affairs/QA

**Date:** June 21, 1996