← Product Code [JDR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR) · K041064 # BIOKNOTLESS RC ANCHOR (K041064) _Depuy Mitek · JDR · May 13, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K041064 ## Device Facts - **Applicant:** Depuy Mitek - **Product Code:** [JDR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR.md) - **Decision Date:** May 13, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair. ## Device Story BioKnotless RC Anchor is a preloaded, absorbable, disposable suture anchor/inserter assembly; facilitates soft tissue-to-bone fixation without manual knot tying. Device comprises a molded Poly(L-lactide) absorbable anchor and a non-absorbable suture loop (Ethibond or Panacryl) with a utility loop (Ethibond Excel). Used by surgeons in clinical settings for rotator cuff repair. Surgeon inserts anchor into bone; suture assembly secures soft tissue. Eliminates need for complex knot-tying maneuvers during surgery; simplifies procedure; potentially reduces operative time and improves fixation consistency. Biocompatibility testing confirms non-toxic, non-irritating, and non-cytotoxic profile. ## Clinical Evidence No clinical data. Biocompatibility studies were performed to demonstrate safety. ## Technological Characteristics Absorbable one-piece suture anchor constructed of molded Poly(L-lactide) polymer. Suture assembly includes non-absorbable Ethibond or Panacryl anchor loop and Ethibond Excel utility loop. Disposable, preloaded inserter assembly. Mechanical fixation principle. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - BioKnotless Anchor ([K002639](/device/K002639.md)) - Panalok RC Anchor ([K964013](/device/K964013.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}------------------------------------------------ K041064 pg 172 ## MAY 1 3 2004 ## 510(k) Summary -- BioKnotless RC Anchor | Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Allyson Barford
Regulatory Affairs Associate
DePuy Mitek
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-2794
Facsimile: 781-278-9578
e-mail: abarford@dpyus.jnj.com | | Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple
Common/Usual Name: Appliance for reconstruction of bone to
soft tissue
Proprietary Name: BioKnotless RC Anchor | | Device Classification | Screw, Fixation, Bone Staple devices have been classified as Class II,
GAM and MAI according to 21 CFR 888.3030. No performance
standards have been established under Section 514 of the Food, Drug
and Cosmetic Act for Screw, Fixation, Bone Staple devices. | | Indications for Use | The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft
tissue to bone fixation in association with adequate post-operative
immobilization as follows:
Shoulder: Rotator cuff repair. | | Device Description | The BioKnotless RC anchor is a preloaded absorbable disposable
suture anchor/inserter assembly designed to allow soft tissue repair to
bone without the need for knot tying. The suture assembly is made up
of a non-absorbable Ethibond or Panacryl anchor loop and a utility
loop constructed of non-absorbable Ethibond Excel suture (green, | ## Special 510(k) Premarket Notification: BioKnotless RC Anchor DePuy Mitek CONFIDENTIAL {1}------------------------------------------------ pge 2/2 #2/0). The Ethibond and Panacryl sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer. Anchor to be non-toxic, non-irritating, and non-cytotoxic. Based on the type of changes being made and the fact that the Substantial Equivalence BioKnotless RC represents the same fundamental scientific technology as the existing BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013); Mitek believes the BioKnotless RC Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013) manufactured by DePuy Mitek. Biocompatibility studies have demonstrated the BioKnotless RC Safety {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings. The seal is black and white and appears to be a logo or emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 3 2004 Ms. Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062 Re: K041064 Trade/Device Name: BioKnotless RC Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codc: JDR and MAI Dated: April 5, 2004 Received: April 23, 2004 Dear Ms. Barford: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encrosaly to ttg. And enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic (110) (110) and the device, subject to the general controls provisions of the Act. The 1 ou may) are controls provisions of the Act include requirements for annual registration, listing of general controls pro resurving 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 If your device is classinod controls. Existing major regulations affecting your device can may be subject to basil as a sublimations, 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 I lease of a rised a determination that your device complies with other requirements of the Act that 1 21 haral statutes and regulations administered by other Federal agencies. You must or any I 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. {3}------------------------------------------------ Page 2 - Ms. Allyson Barford This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow your to ocean finding of substantial equivalence of your device to a legally premated predicated. " ce 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), please If you dome of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whisorananing of responsibilities under the Act may be obtained from the Oinor goneral intonnational 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 vours, Sincerely yours, Mark N. Mellema 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 {4}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K041064 Device Names: BioKnotless RC Anchor Indications for Use: The Mitek BIOKNOTLESS RC Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair. l Mark N. Milken Division of General, Restorative, and Neurological Devices 510(k) Number K091064 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OI Over-the-Counter Use ***_*** Ab Special 510(k) Premarket Notification: BioKnotless RC Anchor DePuy Mitek CONFIDENTIAL --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K041064](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K041064) **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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