← Product Code [HWC](/productcode/HWC) · K014304 # BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S (K014304) _Triage Medical, Inc. · HWC · Mar 27, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K014304 ## Device Facts - **Applicant:** Triage Medical, Inc. - **Product Code:** [HWC](/productcode/HWC.md) - **Decision Date:** Mar 27, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use This device is indicated for use in the general management of fractures and soft tissue repair in light bearing applications with proper postoperative immobililzation. ## Device Story Bone-Lok™ Bioabsorbable Compression Anchor; available with or without titanium fixture. Device provides bone fixation for fractures and soft tissue repair. Used in orthopedic surgical procedures; operated by surgeons. Provides mechanical compression to stabilize bone or soft tissue during healing. Bioabsorbable material facilitates gradual load transfer; titanium fixture provides additional structural support where applicable. Postoperative immobilization required for light bearing applications. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Bioabsorbable material; optional titanium fixture. Classification: 21 CFR 888.3040, Class II, Product Code HWC. Mechanical fixation device. ## 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. ## 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}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/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 a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 7 2002 Mr. Brad Culbert Vice President, Engineering Research and Development Triage Medical, Inc. 13700 Alton Parkway Suite 167 Irvine, Calfornia 92618 Re: K014243 and K014304 Trade/Device Name: Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: December 21 and December 28, 2001 Received: December 26 and December 31, 2001 Dear Mr. Culbert: We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Brad Culbert Please be advised that FDA's issuance of a substantial equivalence determination does not mean r teaso oe acribed that its resemination that your devices comply with other requirements of the Act that I Dri has made a actorinations administered by other Federal agencies. You must or any I catal stututes and regaranents, including, but not limited to: registration and listing (21 Comply with an the rice 5 requirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your devices as described in your Section 510(k) I this letter will anow you to begal finding of substantial equivalence of your devices to legally premarket notification - results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and If you desire specific advice for for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP at 0675 . Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 21 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation ontined, "Thisoranaling on your responsibilities under the Act may be obtained from the Ource general information of your car reational 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, Mark McMillan 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 {2}------------------------------------------------ Page 1 of 1 510(k) Number (if known):__K014304 Device Name: Bone-Lok™ Bioabsorbable Compression Indications For Use: This device is indicated for use in the general management of fractures and This device is indication for ass litht bearing applications with proper postoperative immobililzation. (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark N. Millen (Division Sign-Off) Division of General. Restorative and Neurological Devices KO14304 (Optional Format 3-10-98) 510(k) Number _ --- **Source:** [https://fda-staging.innolitics.com/device/K014304](https://fda-staging.innolitics.com/device/K014304) **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