← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K050636 # SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS (K050636) _Synthes (Usa) · HWC · Apr 21, 2005 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K050636 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Apr 21, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and ostetotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. ## Device Story Synthes 3.0 mm Headless Compression Screws are metallic bone fixation fasteners used by surgeons for small bone fracture fixation and arthrodesis. The device is a cannulated, self-drilling, self-tapping screw featuring a stardrive mechanism and a threaded head designed to be countersunk into bone. Available in stainless steel or titanium alloy, with thread lengths from 10 mm to 40 mm. The device provides mechanical compression across fracture sites or joints to facilitate healing. It is intended for clinical use by orthopedic or hand surgeons in an operating room setting. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to the predicate device. ## Technological Characteristics Materials: Stainless Steel and Titanium Alloy. Design: Cannulated, self-drilling, self-tapping, headless screw with stardrive mechanism. Dimensions: 3.0 mm diameter, 10-40 mm thread lengths. Energy source: None (manual surgical instrument). Sterilization: Not specified. ## 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 - Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded Washer ## 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}------------------------------------------------ KOSD636 Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word and logo. There is a registered trademark symbol to the right of the word. APR 2 1 2005 | 3.0 | 510(k) Summary | Page 1 of 1 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
(610) 719-5000 | | | Device Name: | Synthes 3.0mm Headless Compression Screws | | | Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation
Fastener. | | | Predicate Devices: | Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded
Washer | | | Device Description: | The Synthes 3.0 mm Headless Compression Screws are cannulated
and are self-drilling / self-tapping with a stardrive mechanism, and
have a threaded head which can be countersunk into the bone. The
screws are available in short and long thread lengths ranging from
10 mm to 40 mm. The screws are available in Stainless Steel and a
Titanium Alloy. | | | Intended Use: | The Synthes 3.0 mm Headless Compression Screws are intended
for fixation of intra-articular and extra-articular fractures and non-
unions of small bones and small bone fragments; arthrodeses of
small joints; bunionectomies and ostetotomies. Examples include,
but are not limited to scaphoid and other carpal bones, metacarpals,
tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head
and radial styloid. | | | Substantial
Equivalence: | Information presented supports substantial equivalence. | | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 1 2005 Ms. Sheri L. Musgnung Senior Regulatory Specialist Synthes (USA) 1302 Wrights Lane West Chester, Pennsylvania 19380 Re: K050636 Trade/Device Name: Synthes (USA) 3.0 mm Headless Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 10, 2005 Received: March 11, 2005 Dear Ms. Musgnung: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocures in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manation in the Medical Device Amendments, or to Conniered price to May 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices that have been rochasined in avere approval of a premarket approval application (PMA). and Cosmetic 71ct (11ct) that do not request in the general controls provisions of the Act. The Tou may, uteretore, market are as act include requirements for annual registration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is eassified (dee ass ( ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Peachards concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DA 3 issuates or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it cochal statutes and regarations ancluding, but not limited to: registration and listing (21 comply with an the Act 31equirements, nieteams, and manufacturing practice requirements as set CTN in the quality systems (QS) certer an 800); and If applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2- Ms. Sheri L. Musgnung This letter will allow you to begin marketing your device as described in your Section 5 0(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA finding of substantial equivalence of the s premarket notification: "The PDF Imaning sification 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), please If you desire specific advice for your do not to read to car and the regulation entitled, the regulation Contact the Office of Comphalled at (210) = 16 = 16 = 1 = 1 807.97). You may obtain "Misbranding by reletence to premarket noultied.com the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or and findex bird Manufacturers, Internet and Consailer risolors of the cov/cdrh/industry/support/index.html. Sincerely yours, Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word, adding a sense of completion to the design. The registered trademark symbol is located to the right of the word. of Page 1 Indications for Use 510(k) Number (if known): Synthes (USA) 3.0 mm Headless Compression Screws Indications for Use: Device Name: 2.0 The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular 1.0 mm Headless Compression of world hones and small bones fragments: The Synthes 3.0 mm Headless Compression of small bones and small bones fragments; and extra-articular fractures and non-unions of small bones include, hul a and extra-articular fractures and noll-miss and osteologies. Examples include, but are not arthrodeses of small joints; bunionectomies and osterolo materas; patella, ulpar arthrodeses of small joints; outlouccomes and corocolorized = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = minted to soapitellum, radial head and radial styloid. Prescription Use _ X (Per 21 CFR 801.109) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Styd Clurlo Concurrence of CDRH, Office of Device Evaluation (ODE) Sign-( Diff (Division Division of Seneral, Restorative and Nourological Devices 510(K) Number: K050636 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K050636](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K050636) **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