NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM

K961727 · Intermedics Orthopedics · LZO · Jul 19, 1996 · Orthopedic

Device Facts

• Record ID: K961727
• Device Name: NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
• Applicant: Intermedics Orthopedics
• Product Code: LZO · Orthopedic
• Decision Date: Jul 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.

Device Story

Femoral component of total hip prosthesis; used in cemented arthroplasty. Features Sulzer 12/14 threaded trunnion for attachment to ceramic femoral heads; proximal body includes extraction hole and slotted flange for trochanter wiring; proximal-medial keel for rotational stability; grit-blasted distal portion with longitudinal grooves for bone cement interdigitation; distal hole for optional canal centralizer. Implanted by orthopedic surgeons in clinical settings. Provides structural replacement for proximal femur; restores joint function; facilitates revision via extraction hole.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Forged/wrought CoCr alloy. Design: Femoral stem with proximal-medial keel, slotted flange, extraction hole, and grit-blasted distal surface. Connection: Sulzer 12/14 threaded trunnion. Fixation: Cemented. Dimensions: 140 mm and 160 mm lengths.

Indications for Use

Indicated for patients with intertrochanteric, comminuted, or femoral neck fractures, trochanteric non-union, calcar/femoral neck erosion, tumors, or requiring revision total hip arthroplasty with proximal femoral bone loss. Indicated for patients who have reached skeletal maturity.

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

• Calcar Replacement Stem (K945516)
• Omnifit Head/Neck Hip Stem (510(k) No. unknown)
• HNR (Head and Neck Replacement) Stem (K902712)
• Cemented Calcar Stem (510(k) No. unknown)

Reference Devices

• Biolox ceramic heads (K923934)
• Zirconia ceramic heads (K942330)

Submission Summary (Full Text)

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K961727

JUL 19 1996

510(k) Premarket Notification
Summary of Safety and Effectiveness
for
Calcar Replacement Hip Stem

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 Calcar Replacement Hip Stem.

Submitter:
Intermedics Orthopedics, Inc. (IOI)
9900 Spectrum Drive
Austin, Texas, 78717
Tel.: [phone]
Fax: [phone]

Contact Person:
Regarding this submission:
Name: Sam Mirza
Tel.: [phone]
Fax: [phone]

Official Correspondent
Name: Jacquelyn Hughes
Tel.: [phone]
Fax.: [phone]

Date: February 15, 1996

Proprietary name: Natural Hip System
Calcar Replacement Hip Stem

Common Name: Total Hip Prosthesis - Femoral Component

Classification name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353).

Predicate Devices: The features employed by Calcar Replacement Hip Stem are substantially equivalent to the features employed by the following predicate legally marketed devices:

- Calcar Replacement Stem: IOI - (510(k) #K945516);
- Omnifit Head/Neck Hip Stem: Osteonics Corporation (510(k) No. unknown to IOI);
- HNR (Head and Neck Replacement) Stem: Howmedica Corporation (510(k) No. K902712); and
- Cemented Calcar Stem: Depuy Inc. (510(k) No. unknown to IOI);

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# Device Description:

The Calcar Replacement Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to the IOI's femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured threaded bore. The Biolox and Zirconia ceramic heads are available in two sizes, 28mm inner diameter (ID), and 32mm ID. The Biolox and ceramic bearing heads have been determined substantially equivalent by the FDA via 510(k) #'s K923934 and K942330.

The proximal body of the hip stem features an extraction hole in the anterior/posterior direction to facilitate removal of the hip stem if revision becomes necessary. The proximal body of the hip stem features a sloted flange which allows the surgeon the option of wiring the trochanter. The Calcar Replacement Hip Stem employs a keel below the proximal-medial flange for enhanced rotational stability.

The grit blasted distal portion of the hip stem employs two medial longitudinal grooves and is oval shaped. The grit blasted surfaces provide enhanced interdigitation with bone cement. The Calcar Replacement Hip Stem is available with a distal hole for optional use with the PMMA canal centralizer.

# Intended Use:

The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.

1. Patient conditions of intertrochanteric, comminuted or femoral neck fracture
2. Trochanteric nonunion
3. Erosion of the calcar or femoral neck
4. Revision total hip arthroplasty involving bone loss in the proximal femur
5. Tumors.

Patient selection will be largely dependent on patient's age, general health, conditions of available bone stock, any prior surgery and anticipated further surgeries. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity.

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# Summary of Technological Characteristics:

A side by side tabular comparison of the characteristics of the Calcar Replacement Hip Stem to those of the currently marketed IOI and competitive devices follows:

| Characteristics | Subject Device
Calcar Replacement HipStem | Predicate Devices | | |
| --- | --- | --- | --- | --- |
| | | Calcar Replacement Stem | Omnifit Head/Neck Hip Stem | Head/Neck Replacement System |
| Manufacturer | Intermedics Orthopedics, Inc. | Intermedics Orthopedics, Inc. | Osteonics Corporation | Howmedica Inc. |
| 510(k) No. | - | K945516 | K902712 | Unknown to IOI |
| Intended Use | Cemented | Cemented | Cemented | Cemented |
| Material | Forged/Wrought CoCr Alloy | Cast CoCr Alloy | Cast CoCr Alloy | CoCr Alloy |
| Slotted Flange | Yes | Yes | Yes | Yes |
| Extraction Hole | Yes | Yes | Yes | Yes |
| Collar | Yes | Yes | Yes | Yes |
| Proximal Medial Keel | Yes | Yes | Yes | Yes |
| Distal Hole | Yes | Yes | Yes | Yes |
| Stem length | 140 and 160 mm | 140 and 160 mm | 120, 140, 160, and 190 mm | 135, 165, and 185mm |