NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM

• K Number: K961727
• Device Name: NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
• Manufacturer: INTERMEDICS ORTHOPEDICS
• Date Cleared: 1996-07-19 ( 77 days)
• Product Code: LZO
• Regulation Number: 888.3353
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K923934 , K942330 , K945516 , K902712
• Predicate For: N/A

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.

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 stern 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.

AI/ML Overview

This document pertains to the 510(k) Premarket Notification for the Calcar Replacement Hip Stem, a medical device, and therefore does not contain information about software acceptance criteria or studies involving AI/ML performance.

The provided text describes the device's technical characteristics and its intended use, along with a comparison to predicate devices. It does not include any information related to:

• Acceptance criteria for software performance
• Studies proving device meets acceptance criteria related to software
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used
• How ground truth for a training set was established

The document is a traditional medical device submission, focusing on substantial equivalence to previously cleared devices based on physical design, materials, and intended use, rather than software performance.

Summary

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K961727

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

JUL 19 1996

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 DriveAustin, Texas, 78717Tel.: [phone]Fax: [phone]
Contact Person:	Regarding this submission:Name: Sam MirzaTel.: 512-432-9751Fax: [phone]
	Official CorrespondentName: Jacquelyn HughesTel.: 512-432-9687Fax.: [phone]
Date:	February 15, 1996
Proprietary name	Natural Hip SystemCalcar Replacement Hip Stem
Common Name:	Total Hip Prosthesis - Femoral Component
Classification name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21CFR 888.3353).
Predicate Devices:	The features employed by Calcar Replacement Hip Stem aresubstantially equivalent to the features employed by the followingpredicate legally marketed devices:- Calcar Replacement Stem: IΟΙ - (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 stern 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	Predicate Devices
	CalcarReplacementHipStem	CalcarReplacementStem	OmnifitHead/NeckHip Stem	Head/NeckReplacementSystem
Manufacturer	IntermedicsOrthopedics, Inc.	IntermedicsOrthopedics,Inc.	OsteonicsCorporation	HowmedicaInc.
510(k) No.		K945516	K902712	Unknown toIOI
Intended Use	Cemented	Cemented	Cemented	Cemented
Material	Forged/WroughtCoCr Alloy	Cast CoCrAlloy	CastCoCr Alloy	CoCr Alloy
Slotted Flange	Yes	Yes	Yes	Yes
ExtractionHole	Yes	Yes	Yes	Yes
Collar	Yes	Yes	Yes	Yes
ProximalMedial Keel	Yes	Yes	Yes	Yes
Distal Hole	Yes	Yes	Yes	Yes
Stem length	140 and 160 mm	140 and 160mm	120, 140,160, and190 mm	135, 165,and 185mm

Regulation Number and Section

N/A