← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K991477 # SPIN SNAP-OFF SCREW (K991477) _New Deal, S.A. · HWC · Jul 14, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K991477 ## Device Facts - **Applicant:** New Deal, S.A. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jul 14, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions. ## Device Story SPIN® SNAP-OFF Screw is a self-drilling, self-tapping metallic bone fixation fastener. Device attaches to standard surgical power equipment; upon full insertion into bone, screw head blocks and reaches a specific breaking torque, causing dissociation between screw and snap-off portion. Lengths range from 11 to 14 mm. Used by surgeons in clinical settings for fixation of bone fractures or reconstructions in the foot. Output is a secured bone fixation point. Benefits include simplified installation via snap-off mechanism. ## Clinical Evidence Bench testing only. Rupture torque of the SPIN® SNAP-OFF SCREW was compared against the French Standard NF-F 90414 and found to be in compliance. ## Technological Characteristics Metallic bone fixation fastener made from titanium alloys. Self-drilling and self-tapping design with a cleavable snap-off portion. Dimensions: 11 to 14 mm length. Operates via mechanical torque-limited dissociation. No software or electronic components. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Depuy Twist-off Screw - Howmedica Luhr Screw system - Synthes Cortex Screw - Osteomed M3 Screw ## 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}------------------------------------------------ 14 1999 JUII - Image /page/0/Picture/1 description: The image shows the logo and contact information for NEWDEAL SA. The logo "newdeal" is displayed in a stylized font. Below the logo is the company's address: 31 RUE DE LA CONVENTION, 'ARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE. The telephone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 16. INTERNET EMAIL : NEWDEALFR@AOL.C K991477 1999 - 1999 ## 3. SUMMARY OF SAFETY AND EFFECTIVENESS - SPONSOR IDENTIFICATION: A. NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE Tél. : (33) 4 74 78 15 15 Fax : (33) 4 74 78 15 16 #### B. ESTABLISHMENT REGISTRATION NUMBER: Pending ## OFFICIAL CONTACT PERSON C. Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 Tel. : (301) 279 -2899 Fax : (301) 294-0126 #### DATE OF PREPARATION OF THIS SUMMARY: D. April 15, 1999 #### E. PROPRIETARY (TRADE) NAME: SPIN® SNAP-OFF SCREW ### F. COMMON NAME: Bone fixation screw, Self drilling and self tapping snap-off screw Image /page/0/Picture/15 description: The image shows a collection of chromosomes. There are 10 chromosomes in total, arranged in a row. There are also a few smaller, darker spots above the chromosomes, which may be additional genetic material or artifacts in the image. {1}------------------------------------------------ - CLASSIFICATION NAME AND REFERENCE G. Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040) - Class II H. PROPOSED REGULATORY CLASS: - I. DEVICE PRODUCT CODE: 87HWC - J. PANEL CODE: 21 CFR par. 888.3040 ## K. DESCRIPTIONOF DEVICE: The SPIN® SNAP-OFF Screw is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14 mm. #### INTENDED USE: L. The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions. #### M. INDICATIONS FOR USE: The SPIN® SNAP-OFF Screw is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include: -Weil osteotomy - Unicortical small bone fixation #### PREDICATE DEVICE: N. The SPIN® SNAP-OFF Screw is substantially equivalent to the Depuy Twist-off Screw, the Howmedica Luhr Screw system, the Synthes Cortex Screw and the Osteomed M3 Screw. ### 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the SPIN® SNAP-OFF Screw and the predicate devices have the same intended use and all are indicated for fixing small fractures or osteotomies. All are made from titanium alloys. The Twist-off Screw, the Luhr Screw system, and the off Screw have a cleavable part. Both supply instrumentation sets. #### P. SUMMARY OF STUDIES: Rupture torque of the. SPIN® SNAP-OFF SCREW was compared with requirement of the French Standard NF-F 90414 and found to have a resistance to torsion in compliance with the selected standard. 000001 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 14 1999 Norman F. Estrin, Ph.D., RAC President Representing NewDeal SA Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854 Re: K991477 > Trade Name: Spin® Snap-Off Screw Regulatory Class: II Product Code: HWC Dated: April 26, 1999 Received: April 28, 1999 Dear Dr. Estrin: 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 regulations affecting your device can be found in the Code of Federal Regulations. 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 regulation (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 action. In addition, FDA may publish further announcements 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 – Dr. Norman F. Estrin 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "CONFIDENTIAL" in large, bold letters. Below the word, the text "Page 1 of 1" is printed in a smaller font. The text suggests that this is the first page of a confidential document. # 510(k) Number (if known): 长9914 77 # SPIN® SNAP-OFF SCREW® Device Name: Indications for Use: The SPIN® SNAP-OFF SCREW® is indicated for fixing the elective osteotomies in the metatarsal and phalanges of the foot only. Examples include: > Weil osteotomy Lesser metatarsal osteotomies (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use × OR Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) to cellefio al Restorative Device --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K991477](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K991477) **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. 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