Knee
ACL repairs
PCL repairs
Extra-capsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs
Vastus medialis obliquus advancement
Iliotibial band tenodesis

Shoulder
Acromioclavicular separation repairs
Biceps tenodesis

Foot and Ankle
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Flexor hullucis longus (FHL) Tendon transfers

Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicylitis repair
Scapholunate ligament reconstruction
Tendon transfers
Carpometacarpal joint arthroplasty

NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.

Device Description

The Smith & Nephew's BIOSURE REGENESORB interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The interference screw is provided sterile, for single use only.

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

This document is a 510(k) premarket notification clearance letter from the FDA for the BIOSURE REGENESORB Interference Screw. It states that the device is "substantially equivalent" to legally marketed predicate devices.

While the document mentions "Mechanical testing data for insertion and pull out (fixation) testing demonstrates the BIOSURE REGENESORB interference screw is substantially equivalent to the currently marketed predicate devices," and "The in vitro degradation of the device is substantially equivalent to the predicate BIOSURE HA (K080358)," it does not provide specific details about:

Acceptance criteria: No numerical or qualitative criteria are listed for any performance metrics.
Reported device performance: Specific values for insertion force, pull-out strength, or degradation rates are not provided.
Study design details: There is no information on sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or whether MRMC or standalone studies were conducted.

The document's purpose is to grant clearance based on substantial equivalence, not to present the detailed results of performance studies against specific acceptance criteria. To get the information you are looking for, you would typically need to consult the full 510(k) submission, which is not included in the provided text.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2015

Smith & Nephew Incorporated Mr. Vivek Mukhatyar Regulatory Affairs Specialist II 150 Minuteman Drive Andover, Massachusetts 01810

Re: K142948

Trade/Device Name: BIOSURE REGENESORB Interference Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: December 17, 2014 Received: December 18, 2014

Dear Mr. Mukhatyar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142948

Device Name The BIOSURE REGENESORB Interference Screw

Indications for Use (Describe)

The BIOSURE REGENESORB Interference Screw is indicated for the reattachment, tendon, soft tissue, or bone-tendon-bone for the following indications:

Knee

ACL repairs PCL repairs Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis

Shoulder Acromioclavicular separation repairs Biceps tenodesis

Foot and Ankle Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Flexor hullucis longus (FHL) Tendon transfers

Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Carpometacarpal joint arthroplasty

NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bone-tendon-bone procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Date Prepared: December 16th, 2014

SUBMITTER INFORMATION	CONTACT INFORMATION
Smith & Nephew, Inc.	Vivek Mukhatyar
150 Minuteman Road	Regulatory Affairs Specialist II
Andover, MA 01810	Phone: (978)749-1043Fax: (978)749-1443

DEVICE NAME (UNMODIFIED)
Trade or proprietary name	BIOSURE REGENESORB interference screw
Common or usual name	Soft Tissue Fixation Device
Classification name	21 CFR §888.3030
Device Class	Class II
Product Code	MAI

LEGALLY MARKETED PREDICATE DEVICE

The Smith & Nephew BIOSURE REGENESORB interference screw is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

Predicate Device	510(k)Number	Clearance Date
BIOSURE HEALICOIL PKInterference Screw	K140879	07/21/2014
PLLA/HA Screw (BIOSURE HA)	K080358	12/14/2004
HEALICOIL Absorbable SutureAnchor (HEALICOILREGENESORB)	K123393	4/11/2013

DEVICE DESCRIPTION

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INTENDED USE

The BIOSURE REGENESORB Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications:

Knee

Shoulder

Acromioclavicular separation repairs Biceps tenodesis

Foot and Ankle

Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Flexor hullucis longus (FHL) Tendon transfers

Elbow, Wrist, and Hand

Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Carpometacarpal joint arthroplasty

NOTE: Only the 6mm, 7mm, 8mm, 9mm and 10mm diameter screws are intended to be used for bonetendon-bone procedures.

TECHNOLOGICAL CHARACTERISTICS

Smith & Nephew BIOSURE REGENESORB interference screw is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices - Smith and Nephew BIOSURE HEALICOIL PK interference screw (K140879), HEALICOIL Absorbable Suture Anchor and BIOSURE HA (K080358) and raises no new issues of safety and efficacy. Smith & Nephew BIOSURE REGENESORB interference screw and the predicate Smith & Nephew HEALICOIL Absorbable Suture Anchor (K123393) are manufactured from the same composite material. Smith & Nephew BIOSURE HEALICOIL interference screw and the predicate BIOSURE HA (K080358) share the same thread structure and are both absorbable interference screws. BIOSURE REGENESORB has a similar open lattice design to the BIOSURE HEALICOIL PK interference screw (K140879).

SUMMARY OF PERFORMANCE DATA

Mechanical testing data for insertion and pull out (fixation) testing demonstrates the BIOSURE REGENESORB interference screw is substantially equivalent to the currently marketed predicate devices. The in vitro degradation of the device is substantially equivalent to the predicate BIOSURE HA (K080358).

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Substantial Equivalence Information

The substantial equivalence of the BIOSURE REGENESORB interference screw is based on similarities in indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the BIOSURE REGENESORB interference screw is substantially equivalent to its predicates.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.