Who is the manufacturer of APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA?

Intermedics Orthopedics filed the 510(k) submission for APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA (K960535).

What is the FDA product code for APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA?

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

Who can help prepare an FDA 510(k) submission like APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA?

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.

APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA

K960535 · Intermedics Orthopedics · JWH · Apr 23, 1996 · Orthopedic

Device Facts

Record ID	K960535
Device Name	APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
Applicant	Intermedics Orthopedics
Product Code	JWH · Orthopedic
Decision Date	Apr 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
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.

Indications for Use

Indicated for patients requiring total knee arthroplasty, specifically for use with the Apollo Total Knee System components to replace the patellar surface.

Regulatory Classification

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

Related Devices

K061340 — 23 MM SINGLE-PEG PATELLA COMPONENT · Biomet Manufacturing, Inc. · Sep 25, 2006
K020830 — SCORPIO INSET PATELLAR COMPONENT · Howmedica Osteonics Corp. · Jun 6, 2002
K961483 — DURACON ALL POLYETHYLENE PATELLA II · Howmedica Corp. · Jul 9, 1996
K122218 — ADVANCE TOTAL KNEE SYSTEM-PATELLA · Wrightmedicaltechnologyinc · Mar 21, 2013
K961482 — DURACON INSET PATELLA WITH CENTRAL PEG · Howmedica Corp. · Jul 5, 1996

Submission Summary (Full Text)

{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