← Product Code [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ) · K984432 # DALL-MILES CABLE GRIP (A-GRIP) (K984432) _Howmedica Osteonics Corp. · JDQ · Feb 24, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K984432 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [JDQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ.md) - **Decision Date:** Feb 24, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3010 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Dall-Miles Cable Grip is intended to be used for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy. ## Device Story Dall-Miles Cable Grip (A-Grip) is a bone fixation cerclage device used in orthopedic hip surgery. It provides horizontal and vertical stabilization of the greater trochanter following osteotomy. The device consists of a grip component with a central hook (with or without a cannulated groove) and a tension band. It is used in conjunction with Dall-Miles cables and sleeves and the FX-Cablelok System. Modifications from the predicate include a reduction to a single central hook and new crimping mechanisms for vertical fixation, located either in the distal hooks of the grip or the tension band component. The device is intended for use by surgeons in an operating room setting to stabilize bone fragments, aiding in healing and revision procedures. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Bone fixation cerclage system. Components include a grip with a central hook and a tension band. Features mechanical crimping mechanisms for cable securing. Designed for use with Dall-Miles cables and sleeves. Mechanical 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 - Osteonics FX-Cablelok Grip Components ([K980594](/device/K980594.md)) - Howmedica Dall-Miles Trochanter Cable Grip System ([K844068](/device/K844068.md)) - Howmedica Dall-Miles Trochanter Cable Grip System ([K900926](/device/K900926.md)) - Howmedica Dall-Miles Trochanter Cable Grip System ([K971741](/device/K971741.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}------------------------------------------------ 1984432 ## 510(k) Summary Proprietary Name: Dall-Miles Cable Grip Common Name: Bone Fixation Cerclage Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010 Proposed Requiatory Class: Class II Device Product Code: OR(87) JDQ For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Osteonics 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 12-11-98 The Dall-Miles Cable Grip (A-Grip) described in this submission is a modification of the previously cleared Osteonics FX-Cablelok™ grip components. The intended use of the modified device is the same as the current device; for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy. The vertical fixation feature of the device aids in the fixation of the trochanter in those instances where additional stabilization may be required, for example revision cases. These grips are intended to be used in conjunction with the Dall-Miles cables and sleeves and the FX-Cablelok System. The design modifications are outlined below: The two proximal hooks in the current grip have been reduced to one centrally positioned hook in the new grip. This central hook is available with and without a cannulated groove for the passage of cable. A hole in the central hook allows for the passage of cable that provides the vertical fixation feature of the device. {1}------------------------------------------------ The flares on the anterior and posterior limbs (used for the passage of cable during vertical fixation) have been removed. Two new designs have been developed to provide for vertical fixation. The first design incorporates a crimping mechanism in each of the distal hooks of the grip. The cable is passed through the grip and a "tension band" device (that is placed below the trochanter, similar to the existing FX-Cablelok sleeve design) and secured by crimping the hooks on the grip. The second design incorporates a crimping mechanism directly in the tension band component. With this design, the cable is passed through the grip and the tension band device and secured by crimping the tension band component. The standard method for horizontal fixation on the current design is still provided in both of the new designs. The substantial equivalence of the modified Dall-Miles Grip is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Osteonics' FX-Cablelok Grip Components (K980594) and Howmedica's Dall-Miles Trochanter Cable Grip System (K844068, K900926, and K971741). {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 4 1999 Mr. John Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584 K984432 Re : Dall-Miles Cable Grip Modification Trade Name: Regulatory Class: II Product Code: JDQ and LYT Dated: December 11, 1998 December 14, 1998 Received: Dear Mr. Dichiara: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ## Page 2 - Mr. John Dichiara This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use 510(k) Number (if known): k 984432 Device Name: Dall-Miles Cable Grip (A-Grip) Indications for Use: . The Dall-Miles Cable Grip is intended to be used for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy. (Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | X | |----------------------|---| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | | |----------------------|--| |----------------------|--| (Optional Format 1-2-96) (Division Sign-Off) | Division: | Restorative Devices | |---------------|---------------------| | 510(k) Number | K984432 | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K984432](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K984432) **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