← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K020677 # GAMMA 3 LAG SCREW (K020677) _Howmedica Osteonics Corp. · HSB · Mar 29, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K020677 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Mar 29, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. Intended Use for the Long Length Dyax Nail: The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures. Intended Use for the Trochanteric Dyax Nail: The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur. ## Device Story Gamma 3 Lag Screw is an orthopedic fixation component designed for use with Long Length Dyax Nail and Trochanteric Dyax Nail systems. Device functions as a lag screw for internal fixation of femoral fractures. Modification from previous Dyax Lag Screw includes changes to thread diameter, thread radius, and cutting flute design. Used by orthopedic surgeons in clinical/surgical settings to stabilize fractures of femoral neck and shaft. Output is mechanical fixation of bone segments to facilitate healing. Benefits include improved fracture stabilization through modified thread and flute geometry. ## Clinical Evidence No clinical data provided; substantial equivalence supported by design modification analysis. ## Technological Characteristics Orthopedic lag screw; modifications include thread diameter, thread radius, and cutting flute design. Intended for use with intramedullary fixation rods (21 CFR 888.3020). ## Regulatory Identification An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. ## Predicate Devices - Dyax Nail Lag Screw ([K020677](/device/K020677.md)) ## Related Devices - [K200869](/device/K200869.md) — Gamma3 System · Stryker Trauma GmbH · Jul 22, 2020 - [K032244](/device/K032244.md) — GAMMA 3 NAIL SYSTEM · Howmedica Osteonics Corp. · Aug 8, 2003 - [K034002](/device/K034002.md) — GAMMA3 NAIL SYSTEM · Howmedica Osteonics Corp. · Jan 15, 2004 - [K964259](/device/K964259.md) — SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION · Synthes (Usa) · Jan 9, 1997 - [K021026](/device/K021026.md) — S2 FEMORAL NAIL · Howmedica Osteonics Corp. · Apr 25, 2002 ## Submission Summary (Full Text) {0}------------------------------------------------ Design Modification of the Dyax Lag Screw to the Gamma 3 Lag Screw Special 510(k) Premarket Notification # Special 510(k) Summary: Design Modification of the Dyax Lag Screw to the Gamma 3 Lag Screw #### Submission Information Contact Person: Name and Address of the Sponsor of the 510(k) Submission: Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677 Karen Ariemma Regulatory Affairs Specialist Date of Summary Preparation: February 27, 2002 ### Device Identification Gamma 3 Lag Screw Proprietary Name: Intramedullary Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020 This Special 510(k) submission is intended to address a design modification of the Dyax Lag Screw to create the subject device which is referred to as the Gamma 3 Lag Screw. The design modification involves changes to the thread diameter; thread radius and cutting flute design. The subject device is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. The design modification involves changes to the thread diameter; thread radius and cutting flute design There is no change in intended use for the modified device when compared to the previously cleared product. The subject Gamma 3 Lag Screws are substantially equivalent to the existing design of Dyax Nail Lag Screw that were determined substantially equivalent via the 510(k) process. 2 K020677 page 1 of 1 **MAR 2 9 2002** {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 9 2002 Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677 Re: K020677 Trade/Device Name: Gamma 3 Lag Screw Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 27, 2002 Received: March 1, 2002 Dear Ms. Ariemma: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a sove and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfalse in the encrease of 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ # Page 2 - Ms. Karen Ariemma This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, ho Mark N-Millisser Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): K () JO6 7 7 Device Name: Gamma 3 Lag Screw Indications For Use: The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. ## Intended Use for the Long Length Dyax Nail The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures. ### Intended Use for the Trochanteric Dyax Nail The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Mark N. Mulkerson Division Sign-Division of General, Restorative and Neurological Devices S . . K ) Number _ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K020677](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K020677) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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