← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K962236 # SCARF THREAD-HEAD SCREW (K962236) _Landos, Inc. · HWC · Sep 20, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K962236 ## Device Facts - **Applicant:** Landos, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Sep 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. ## Device Story Cannulated bone fixation screw; titanium alloy construction; lengths 10-32 mm. Used by orthopedic surgeons for internal fixation of foot osteotomies. Provides mechanical stability to bone fragments during healing. Implanted via surgical procedure; cannulated design allows placement over guidewire. Benefits patient by maintaining bone alignment post-osteotomy. ## Clinical Evidence Bench testing only. Rupture torque testing performed per French Standard NF-F-90-414; device demonstrated compliance with torsion resistance requirements. ## Technological Characteristics Cannulated bone screw; titanium alloy; lengths 10-32 mm (2 mm increments); hexagonal socket head; threaded design. ## 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 - Medinov-AMP Scarf Screw ([K931155](/device/K931155.md)) - Herbert-Whipple Bone Screw (Zimmer) ([K792022](/device/K792022.md)) - M3 Screw System (Osteomed) ([K924018](/device/K924018.md), 924138) ## 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} Landos Inc. K962236 A SUBSIDIARY OF GROUP LANDANGER CAMUS SEP 20 1996 # 3. SUMMARY OF SAFETY AND EFFECTIVENESS ## MANUFACTURER IDENTIFICATION: Medinov - AMP Z.I. Bapaume 27-31 rue Lucien Langénieux 42335 Roanne Cedex FRANCE ## SPONSOR IDENTIFICATION LANDOS INC. Mr. Jean-Paul Burtin 100 Lindenwood Drive Malvern, PA 19355 ## ESTABLISHMENT REGISTRATION NUMBER: 2530066 ## OFFICIAL CONTACT PERSON: 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: May 22, 1996 ## TRADE NAME: SCARF THREAD-HEAD™ SCREW ## COMMON NAME: Bone Fixation Screw ## CLASSIFICATION NAME AND REFERENCE: Screw, Fixation, Bone (21 CFR, Section 888.3040) Class II ## PROPOSED REGULATORY CLASS: 87HWC ## DEVICE PRODUCT CODE: 87HWC ## PANEL CODE: 87OR 100 Lindenwood Drive • Malvern, PA 19355 Telephone: 610-644-4670 • Fax: 610-644-4429 00001C {1} 000017 DESCRIPTION OF DEVICE: The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments. INTENDED USE: The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. INDICATIONS FOR USE: The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. PREDICATE DEVICE: The SCARF THREAD-HEAD™ SCREW is substantially equivalent to the Medinov-AMP Scarf Screw (K931155), the Herbert-Whipple Bone Screw (Zimmer) (K792022) and the M3 Screw System (Osteomed) (K924018, 924138). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the SCARF THREAD-HEAD™ SCREW, the Scarf Screw and the Herbert-Whipple Bone Screw have the same intended use and all are indicated for fixing small fractures or osteotomies. All are made from Titanium alloys. The SCARF THREAD-HEAD™ SCREW and Scarf Screws are threaded on nearly all their length with the same thread pitch. Both have a thread head and a hexagonal socket. The Scarf screw is not cannulated; the Herbert-Whipple screw is cannulated and is topped with a hexagonal socket. SUMMARY OF STUDIES: Rupture torque of the SCARF THREAD-HEAD™ SCREW was compared with requirements of the French Standard N° NF-F-90-414 and found to have a resistance to torsion in compliance with the selected Standard. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K962236](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K962236) **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