Who is the manufacturer of NATURAL-HIP SYSTEM COCR STEM?

Intermedics Orthopedics filed the 510(k) submission for NATURAL-HIP SYSTEM COCR STEM (K964357).

What is the FDA product code for NATURAL-HIP SYSTEM COCR 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 NATURAL-HIP SYSTEM COCR STEM?

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

What are the predicate devices for NATURAL-HIP SYSTEM COCR STEM?

Natural-Hip System - DRG Hip Stem (Intermedics Orthopedics, Inc.); Premier Hip Stem (Intermedics Orthopedics, Inc.); ODC Hip Stem (Osteonics Corporation); Perfecta IMC Stem (Orthomet Inc.).

Who can help prepare an FDA 510(k) submission like NATURAL-HIP SYSTEM COCR STEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NATURAL-HIP SYSTEM COCR STEM

K964357 · Intermedics Orthopedics · LZO · Jan 27, 1997 · Orthopedic

Device Facts

Record ID	K964357
Device Name	NATURAL-HIP SYSTEM COCR STEM
Applicant	Intermedics Orthopedics
Product Code	LZO · Orthopedic
Decision Date	Jan 27, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Natural-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Stem is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3. Revision of previously failed arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

Device Story

Femoral component of total hip prosthesis; straight stem with proximal wedge design; available in collared/collarless versions. Proximal third grit-blasted with normalization steps to enhance cement bonding. Features Sulzer 12/14 neck trunnion for modular head attachment; distal hole for centralizer; proximal PMMA centralizers for cement mantle uniformity. Used in cemented total or hemi-hip arthroplasty. Implanted by orthopedic surgeons in clinical settings. Provides structural replacement of femoral anatomy; restores joint mobility; reduces pain associated with degenerative or inflammatory joint disease.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use characteristics compared to predicate devices.

Technological Characteristics

Material: Cobalt-Chromium (CoCr) alloy. Design: Straight stem, proximal wedge, grit-blasted surface, normalization steps. Interface: Sulzer 12/14 neck trunnion. Fixation: Cemented application with proximal and distal PMMA centralizers. Single-use.

Indications for Use

Indicated for patients requiring total or hemi-hip replacement due to non-inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), failed previous surgery, or revision of failed arthroplasty. Intended for cemented application only.

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

Natural-Hip System - DRG Hip Stem (Intermedics Orthopedics, Inc.)
Premier Hip Stem (Intermedics Orthopedics, Inc.)
ODC Hip Stem (Osteonics Corporation)
Perfecta IMC Stem (Orthomet Inc.)

Reference Devices

IOI metallic femoral bearing heads (K905781, K913060)
IOI Biolox Bearing Heads (K923734, K942330)
Zirconia Bearing Heads (K944209)
IOI bipolar components (K833404, K873815)
IOI unipolar components (K833403, K934159)
IOI acetabular components (K850793, K920955, K933203, K942406, K941617, K955033, K955739)

Related Devices

K972435 — ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM · Johnson & Johnson Professionals, Inc. · Sep 11, 1997
K963109 — HERITAGE HIP SYSTEM · Zimmer, Inc. · Jan 9, 1997
K961727 — NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM · Intermedics Orthopedics · Jul 19, 1996
K961799 — NATURAL HIP SYSTEM - DRG HIP STEM · Intermedics Orthopedics · Jul 15, 1996
K994007 — MALLORY/HEAD SMOOTH FEMORAL COMPONENT · Biomet, Inc. · Feb 4, 2000

Submission Summary (Full Text)

{0} JAN 27 1997 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## K964357 In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Natural-Hip™ System CoCr Stem. | Submitter: | Intermedics Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717 (512) 432-9900 | | --- | --- | | Date: | January 14, 1997 | | Contact Person: | Jacquelyn Hughes Manager, Regulatory Affairs | | Classification Name: | Hip-joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis, 21 CFR 888.3353. | | Common/Usual Name: | Total Hip Prosthesis - Femoral Component | | Trade/Proprietary Name: | Natural-Hip System CoCr Stem | ## PRODUCT DESCRIPTION The Natural-Hip System CoCr Stem is a straight stem employing a proximal wedge shaped design. The stem is available in both a collared and collarless design. The proximal one-third of the stem's surface is grit blasted. Normalization steps are also located on the proximal portion of the stem. The grit blasted surface and normalization steps enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The Natural-Hip System CoCr Stem employs a Sulzer 12/14 configured neck trunnion for attachment to Intermedics Orthopedics, Inc.’s femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured bore. The Natural-Hip System CoCr Stem has a hole in the distal portion of the stem to allow the use of a distal centralizer for correct distal alignment. The stem also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. This device is intended for single use only. The Natural-Hip System CoCr Stem is intended to be used in conjunction with the following Intermedics Orthopedics, Inc. devices that have been cleared for marketing by the FDA: - IOI metallic femoral bearing heads [510(k)s K905781 and K913060], - IOI Biolox Bearing Heads [510(k)s K923734, K942330], - Zirconia Bearing Heads [510(k) K944209], - IOI bipolar components [510(k)s K833404 and K873815], - IOI unipolar components [510(k)s K833403 and K934159], {1} 4357 IOI acetabular components [510(k)s K850793, K920955, K933203, K942406, K941617, K955033 and K955739]. ## DIAGNOSTIC INDICATIONS The Natural-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Stem is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3. Revision of previously failed arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. ## SUBSTANTIAL EQUIVALENCE The Natural-Hip System CoCr Stem is substantially equivalent to the Natural-Hip System - DRG Hip Stem (Intermedics Orthopedics, Inc.), the Premier Hip Stem (Intermedics Orthopedics, Inc.), the ODC Hip Stem (Osteonics Corporation), and the Perfecta IMC Stem (Orthomet Inc.).