← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K960535 # APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA (K960535) _Intermedics Orthopedics · JWH · Apr 23, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K960535 ## Device Facts - **Applicant:** Intermedics Orthopedics - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Apr 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Apollo Knee System Single Lug Patella is designed to articulate with the various tibial and femoral components of the Apollo Total Knee System. ## Device Story Single-piece all-polyethylene patellar implant; designed for articulation with Apollo Total Knee System femoral/tibial components. Features central single lug for fixation; includes concentric cement groove on stem and discontinuous dovetail cement grooves on posterior surface for bone cement macro-lock and rotational stability. Available in 28mm round and three elliptical sizes (29x32mm, 32x35mm, 35x38mm). Used by orthopedic surgeons in clinical settings during total knee replacement procedures to restore joint function and stability. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Material: Ultra-high molecular weight polyethylene (UHMWPE) per ASTM F648. Design: Single-piece, single-lug geometry with cement grooves for fixation. Dimensions: 28mm round; 29x32mm, 32x35mm, 35x38mm elliptical. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Reference Devices - Smith & Nephew Richards Genesis All-Poly Patella - Zimmer Insall-Burstein II All-Poly Patella - Johnson & Johnson PFC All-Poly Patella - Biomet Maxim All-Poly Patella - Biomet AGC All-Poly Patella - Orthomet Axiom All-Poly Patella ## 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} 510(k) SUMMARY K96 0535 K960535 APR 23 1996 February 5, 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 Intermedics Orthopedics, Inc. Apollo Total Knee System Single Lug Patella. Submitter: Intermedics Orthopedics, Inc. 9900 Spectrum Drive Austin, TX 78717 (512) 432-9900 Contact Person: Jacquelyn Hughes Manager, Regulatory Affairs Classification Name: Knee joint femorotibial metal/polymer semi-constrained cemented prothesis, 21 CFR 888.3530. Common/Usual Name: Single Lug All-Polyethylene Patella Trade/Proprietary: Apollo Total Knee System Single Lug Patella Product Description/Substantial Equivalence: The Apollo Knee System Single Lug Patella is designed to articulate with the various tibial and femoral components of the Apollo Total Knee System. The Single Lug Patella is a one piece component manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The design incorporates a large, round, centrally placed, single lug on the back of the component for fixation. A concentric cement groove is incorporated into the stem of the single lug to aid in cement adhesion. A discontinuous dovetail cement groove has also been incorporated into the flat surface on the back of the patella to aid in achieving a bone cement "macro-lock" and to assist in rotational stability of the implant. The component will be available in a 28mm round design as well as 29mmX32mm, 32mmX35mm, and 35mmX38mm elliptically shaped design. The Apollo Total Knee System Single Lug Patella is also similar to the Smith & Nephew Richards Genesis All-Poly Patella, the Zimmer Insall-Burstein II All-Poly Patella, the Johnson & Johnson PFC All-Poly Patella, the Biomet Maxim All-Poly Patella, the Biomet AGC All-Poly Patella, and the Orthomet Axiom All-Poly Patella. CCC107 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K960535](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K960535) **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