← Product Code [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ) · K961569 # DALL-MILES STAINLESS STEEL BEADED CABLE (K961569) _Howmedica Corp. · JDQ · Jun 24, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K961569 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ.md) - **Decision Date:** Jun 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3010 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material. ## Device Story Stainless steel cable with electron-beam-melted bead on one end; modification of existing cable design. Used with one-sided tensioner in space-constrained surgical sites where two-sided tensioners are unsuitable. Operates as bone fixation cerclage; provides mechanical stabilization for bone segments or grafts. Used by surgeons in OR settings for orthopedic and trauma procedures. Output is physical fixation of bone/graft; assists in fracture reduction and stabilization; facilitates healing by maintaining bone alignment. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Stainless steel cable; electron-beam-melted bead termination. Mechanical fixation device. No software or energy source. ## 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 - Dall-Miles Trochanter Cable Grip System ([K844068](/device/K844068.md)) - Dall-Miles Trochanter Cable Grip System ([K900926](/device/K900926.md)) - Dall-Miles Suture/Beaded Cable ([K953818](/device/K953818.md)) - Ries Cable System ([K875156](/device/K875156.md)) - Control Cable System ([K934557](/device/K934557.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} JUN 24 1996 K961569 510(k) Summary Proprietary Name: Dall-Miles Stainless Steel Beaded Cable Common Name: Bone Fixation Cerclage Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010 Proposed Regulatory Class: Class II Device Product Code: OR(87) JDQ For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7875 - Phone (201) 507-6870 - Fax Date Summary Prepared: April 17, 1996 The Dall-Miles Stainless Steel Beaded Cable is a modification of the existing stainless steel cable. A bead is formed on one end of the cable by melting it with an electron beam. This modification allows the cable to be used with a one-sided Tensioner in those applications where a conventional two-sided Tensioner will not fit. The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material. The substantial equivalence of the Beaded Cable is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557). --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K961569](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K961569) **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