← Product Code [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ) · K962132 # SILKON STAINLESS STEEL CABLE SYSTEM (K962132) _Osteonics Corp. · JDQ · Aug 8, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K962132 ## Device Facts - **Applicant:** Osteonics Corp. - **Product Code:** [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ.md) - **Decision Date:** Aug 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3010 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Osteonics® Silkon™ Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, kyphosis, and lordosis deformities. The Osteonics® Silkon™ Stainless Steel Cable System is also indicated for trochanteric reattachment, sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle. ## Device Story System consists of multi-strand stainless steel cables (single or Y-design) with monofilament leaders and stainless steel crimps. Used for bone fixation/cerclage in orthopedic and spinal procedures. Operated by surgeons in clinical/OR settings to secure bone segments. Provides mechanical stabilization of fractures or deformities. Sterile offering added to existing product line. ## Clinical Evidence No clinical data; bench testing not required as device is identical to predicate. ## Technological Characteristics Multi-strand stainless steel cable; monofilament wire leader; stainless steel crimp. Mechanical fixation device. Sterile. ## Regulatory Identification A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures. ## Predicate Devices - AME® Silkon™ Cable System ([K932687](/device/K932687.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} K962132 AUG - 8 1996 # 510(k) Premarket Notification ## Summary of Safety and Effectiveness for the Osteonics® Silkon™ Stainless Steel Cable System ### Submission Information **Name and Address of the Sponsor of the 510(k) Submission:** Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 **Contact Person:** Chuck Ryan Regulatory Affairs Team Leader **Date of Summary Preparation:** August 2, 1996 ### Device Identification **Proprietary Name:** Osteonics® Silkon™ Stainless Steel Cable System, which includes the following components: - Osteonics® Silkon™ Stainless Steel Single Cable - Osteonics® Silkon™ Stainless Steel Y Cable - Osteonics® Silkon™ Stainless Steel Crimp **Common Name:** Cerclage Fixation Components **Classification Name/Reference:** Bone Fixation Cerclage 21 CFR §888.3010 ### Overview: The purpose of this 510(k) premarket notification is to address the addition of a sterile offering of this system. ### Predicate Device Identification: The components of the Osteonics® Silkon™ Stainless Steel Cable System are substantially Page 1 {1} Osteonics® Silkon™ Stainless Steel Cable System 510(k) Summary equivalent to those of the AME® Silkon™ Cable System, which was determined substantially equivalent by the U.S. Food and Drug Administration (FDA) via 510(k) Premarket Notification #K932687. ## Description of Devices: The Osteonics® Silkon™ Stainless Steel Cable System consists of two designs: a single, multi-strand, stainless steel cable with an individual monofilament wire leader and a stainless steel crimp; or one multi-strand, stainless steel, double cable with a monofilament Y-Leader and two stainless steel crimps. ## Intended Use: The Osteonics® Silkon™ Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, kyphosis, and lordosis deformities. The Osteonics® Silkon™ Stainless Steel Cable System is also indicated for trochanteric reattachment, sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle. ## Statement of Technological Comparison: The designs and stainless steel material characterizing the components of the Osteonics® Silkon™ Stainless Steel Cable System are identical to those of the predicate AME® Silkon™ Cable System. ## Performance Data: As the components of the Osteonics® Silkon™ Stainless Steel Cable System remain identical to those of the predicate AME® Silkon™ Cable System, which has been determined substantially equivalent via 510(k) Premarket Notification #K932687, no additional performance data is deemed necessary. Page 2 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K962132](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K962132) **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