← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K961799 # NATURAL HIP SYSTEM - DRG HIP STEM (K961799) _Intermedics Orthopedics · JDI · Jul 15, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K961799 ## Device Facts - **Applicant:** Intermedics Orthopedics - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Jul 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty. The general indications associated with the use of DRG Stem in total hip arthroplasty include: 1. Patient conditions of 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. ## Device Story Femoral component for total hip arthroplasty; replaces femoral anatomy. Features widened proximal geometry for metaphyseal fit; grit-blasted surface for bone/cement interdigitation; optional proximal collar for cement pressurization; distal centralizer hole. Used in cemented or cementless (press-fit) procedures. Operated by orthopedic surgeons in clinical/OR settings. Provides structural support for hip joint; reduces interface stress; improves fixation. Benefits patients by restoring joint function and reducing pain. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Material: Wrought or Forged CoCr. Design: Proximal wedge-shaped, optional proximal collar, grit-blasted surface below collar, distal centralizer hole. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. ## Regulatory Identification A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Premier Total Hip Stem ([K894051](/device/K894051.md)) - Osteonics ODC Cemented Hip Stem - Osteonics ODC Hip Stem - Perfecta IMC Stem ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JUL 2 96 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 FAX NO. 5128736291 P. 05 JUL 15 1996 K961799 510(k) Premarket Notification Summary of Safety and Effectiveness for Natural Hip System - DRG 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 DRG Hip Stem. Submitter: Intermedics Orthopedics, Inc. (IOI) 9900 Spectrum Drive Austin, Texas. 78717 Tel.: (512) 432-9900 Fax: (512) 432-9291 Contact Person: Regarding this submission: Name: Sam Mirza Tel.: 512-432-9751 Fax: 512-432-9291 Official Correspondent Name: Jacquelyn Hughes Tel.: 512-432-9687 Fax.: 512-432-9291 Date: May 21, 1996 Proprietary name: Natural Hip System - DRG 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 the DRG Hip Stem are substantially equivalent to the features employed by the following predicate legally marketed devices: - Premier Total Hip Stem: Intermedics Orthopaedics Inc. (510(k) #K894051). - Osteonics ODC Cemented Hip Stem: Osteonics Corporation (510(k) number unknown to IOI). - Osteonics ODC Hip Stem: Osteonics Corporation (510(k) number unknown to IOI). {1} JUL-296 10000000000000000000000000000000000000000000000000000 FAX NO. 5128736291 P. 06 ■ Perfecta IMC Stem: Orthomet Inc. (510(k) number unknown to IOI). ## Device Description: The DRG Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented total hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometry for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown. Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface. The distal portion of DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA). ## Intended Use: The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty. The general indications associated with the use of DRG Stem in total hip arthroplasty include: 1. Patient conditions of 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. {2} JUL-2-36 11:30 FAX NO. 5128736291 P.07 # Summary of Technological Characteristics: A side by side tabular comparison of the characteristics of the DRG Hip Stem to those of the currently marketed IOI and competitive devices follows. | Characteristics | Subject Device DRG Hip Stem | Predicate Devices | | | | | --- | --- | --- | --- | --- | --- | | | | Premier Total Hip Stem | ODC Fx Hip Stem | ODC Hip Stem | Perfecta IMC Stem | | Manufacturer | IOI | IOI | Osteonics | Osteonics | Orthomet | | 510(k)# | - | K894051 | Unknown | Unknown | Unknown | | Material | Wrought or Forged CoCr | Titanium alloy | Cast CoCr | Cast CoCr | Forged CoCr alloy | | Intended Use | Cemented/ Cementless | Cemented | Cemented | Cemented | Cemented | | Proximal wedge shaped design | Yes | Yes | Yes | Yes | Yes | | Proximal collar | Available with or without collar | Yes | Yes | Yes | Yes | | Surface Enhancement Via Grit Blasting | Entire length below the collar of the hip stem | Proximal third only | Entire length below the collar | Proximal third only | Proximal third only | | Distal Canal Centralizer | Yes | Yes | No | Yes | Yes | | Neck Lengths | 25-41mm | 35mm | 25-35mm | 25-40mm | Unknown | | Sizes | 5 sizes | 7 sizes | 5 sizes | 7 sizes | 6 sizes | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K961799](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K961799) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com