← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K964951 # KINEMAX PLUS TIBIAL SPACERS (K964951) _Howmedica Corp. · JWH · Feb 24, 1997 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K964951 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia. ## Device Story Kinemax® Plus Tibial Spacers; orthopedic implants for total knee arthroplasty. Input: bone loss on proximal tibia. Operation: spacers (half, full, full angled) attach to tibial baseplates via cement, fixation screws, or fixation pegs; baseplate-spacer assembly cemented to prepared tibia. Used in OR by orthopedic surgeons. Output: augmented tibial baseplate providing stability. Benefit: restores joint stability in presence of bone defects. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: cast Vitallium® alloy (spacers); wrought or cast Vitallium® alloy (fixation screws/pegs). Form factor: half, full, and full angled spacers. Sterilization: sterile. ## 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). ## Predicate Devices - Duracon® Tibial Wedges - Howmedica ([K915512](/device/K915512.md)) - Kinemax® Angled Tibial Wedge - Howmedica ([K884837](/device/K884837.md)) - Insall-Burstein II Half and Full Tibial Wedges - Zimmer ([K872379](/device/K872379.md)) - Maxim Tibial Augmentation Blocks - Biomet ([K915132](/device/K915132.md) and [K922285](/device/K922285.md)) - CKS Tibial Spacers - Techmedica ([K896542](/device/K896542.md), [K901457](/device/K901457.md), [K903286](/device/K903286.md), and [K914072](/device/K914072.md)) ## 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} K 96 4 951 510(k) Summary FEB 24 1997 Device: Kinemax® Plus Tibial Spacers The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia. There are three types of spacers in the Kinemax® Plus Tibial Spacer System: a half spacer, a full spacer, and a full angled spacer. These spacers are fabricated from cast Vitallium® alloy. The fixation screws and pegs used to secure these spacers to the tibial baseplates are fabricated from wrought or cast Vitallium® alloy. These products will be sold sterile. The Kinemax® Plus Tibial Spacers are substantially equivalent to other legally marketed products. Examples of these products are listed below: 1. Duracon® Tibial Wedges - Howmedica (K915512) 2. Kinemax® Angled Tibial Wedge - Howmedica (K884837) 3. Insall-Burstein II Half and Full Tibial Wedges - Zimmer (K872379) 4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285) 5. CKS Tibial Spacers - Techmedica (K896542, K901457, K903286, and K914072) An analysis of equivalent features was presented. For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7431 Facsimile: (201) 507-6870 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K964951](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K964951) **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