← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K981670 # DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW (K981670) _Depuy, Inc. · HWC · Jun 22, 1998 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K981670 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jun 22, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction. ## Device Story Cannulated, fully threaded cancellous bone screws; used for interference fixation of grafts in ACL reconstruction. Available in 7, 8, and 9mm diameters; 20, 25, and 30mm lengths. Profile Round Head version manufactured from titanium alloy; Phantom Absorbable version manufactured from Poly-L-lactic acid. Used by surgeons in clinical settings. Provides mechanical fixation of bone-patellar tendon-bone or soft tissue grafts to bone, facilitating graft stability during healing. ## Clinical Evidence Bench testing only. Mechanical testing in cadaver bone compared insertion torque and pull-out strength of subject devices against predicate devices (DePuy SofThread and Linvatec BioScrew). Results showed comparable performance. ## Technological Characteristics Cannulated, fully threaded cancellous bone screws. Materials: Titanium alloy (Profile Round Head) and Poly-L-lactic acid (Phantom Absorbable). Diameters: 7, 8, 9mm. Lengths: 20, 25, 30mm. Mechanical fixation principle. ## 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 Advantage Fixation Screw System ([K961234](/device/K961234.md)) - DePuy Hyloc Interference Screw ([K955733](/device/K955733.md)) - DePuy Phantom SofThread Soft Tissue Interference Screw ([K980440](/device/K980440.md)) - Linvatec BioScrew Absorbable Interference Screw ([K960652](/device/K960652.md), [K960940](/device/K960940.md)) - Smith & Nephew Donjoy RCI Screw ([K945687](/device/K945687.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}------------------------------------------------ # K981670 #### SUMMARY OF SAFETY AND EFFECTIVENESS | NAME OF FIRM: | DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 | |----------------------|------------------------------------------------------------------------------------------------| | FIRM CONTACT: | Sally Foust
Regulatory Submissions Associate | | TRADE NAME: | DePuy ProfileTM Round Head Interference Screw
DePuy PhantomTM Resorbable Interference Screw | | COMMON NAME: | Bone Screw | | CLASSIFICATION: | 888.3040 Smooth or threaded metallic bone fixation fastener | | DEVICE PRODUCT CODE: | 87 HWC | ## SUBSTANTIALLY EQUIVALENT DEVICES: ·DePuy Advantage Fixation Screw System (K961234) - · DePuv Hyloc Interference Screw (K955733) · DePuy Phantom SofThread Soft Tissue Interference Screw (K980440) • Linvatec BioScrew Absorbable Interference Screw (K960652, K960940) ·Smith & Nephew Doniov RCI Screw (K945687) ### DEVICE DESCRIPTION AND INTENDED USE: The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw). The DePuy Interference Screw Systems are intended to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction. #### BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Profile Round Head and the Phantom Absorbable Interference Screws are similar in design and materials to the DePuy Advantage and Hyloc Interference screws which have been previously been cleared by FDA for interference fixation of bone-patellar tendon-bone grafts in ACL reconstruction. Aside from minor design changes and fewer screw length options, the only difference between this submission and the previously cleared submissions is the additional indication for interference fixation of soft tissue grafts in ACL reconstruction. Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those of the previously cleared DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew indicated for interference fixation of soft tissue grafts in ACL reconstruction. ## 000004 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 2 1998 Ms. Sally Foust Regulatory Submissions Associate DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K981670 DePuy Profile Round Head Interference Screw Trade Name: DePuy Phantom Resorbable Interference Screw Regulatory Class: II Product Codes: HWC and MAI May 11, 1998 Dated: Received: May 12, 1998 Dear Ms. Foust: 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 The general controls provisions of the Act 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 requlation 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. {2}------------------------------------------------ Page 2 - Ms. Sally Foust 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, Cecelia M. Whitton, Ph.D. ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known)_ K 9816 70 Device Name DePuy Interference Screw Systems - Additional Indication/Intended Use Indications for Use: The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction. Concurrence of CDRH, Office of Device Evaluation ============================================================================================================================================================================== A Prescription Use_ (Per 21 CFR 801.109) OR Over-The-Counter Use_ # 000001 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K981670](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K981670) **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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