The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee (ACL Repairs, PCL Repairs, Extra-capsular repairs - Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization - Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus (FLH), 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, Carpal Ligament Reconstruction)

Device Description

Reattachment of ligament, tendon, soft tissue, or bone in, shoulder, foot/ankle, knee, elbow and hand/wrist.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Smith & Nephew Biosure PK Interference Screw." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria and a detailed statistical analysis of device performance.

Therefore, the document does not report on acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically expected for a detailed clinical or diagnostic study.

Instead, the submission states:

Acceptance Criteria & Reported Performance: The document doesn't explicitly list numerical acceptance criteria or detailed performance metrics. It rather asserts "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Biosure PK Interference Screw are substantially equivalent to the Smith & Nephew BIOSURE HA Screw, the Smith & Nephew BioRaptor 2.3PK and the Arthrex Interference Screw." This implies that the device's performance was measured against its predicate devices, and the results were deemed comparable.

Based on the provided text, the remaining information cannot be extracted:

Sample size used for the test set and the data provenance: Not mentioned. The testing mentioned is "performance testing" which likely refers to mechanical or bench testing, not a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set with ground truth is not described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an interference screw, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the validated performance of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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SECTION IV

JAN 3 0 2009

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew Biosure PK Interference Screw

Date Prepared: December 5, 2008

A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

B. Company Contact

Christina Flores

Regulatory Affairs Specialist II

T 508-261-3705

F 508-261-3620

C. Device Name

Trade Name: Biosure PK Interference Screw

Common Name: Screw, Fixation, Bone

Classification Name: fixation fastener

21 CFR 888.3040 - Smooth or threaded metallic bone

Predicate Devices D.

The Smith & Nephew Biosure PK Interference Screw is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew BIOSURE HA Interference Screw (K080358), Smith & Nephew BioRaptor 2.3PK Suture Anchor (K071586), and Arthrex Interference Screw (K062466)

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K083635 2/3
We are smith&nephew

E. Description of Device

Reattachment of ligament, tendon, soft tissue, or bone in, shoulder, foot/ankle, knee, elbow and hand/wrist.

F. Intended Use

The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 25 mm or less are also intended for use in the following procedures:

Knee

ACL Repairs .
PCL Repairs .
Extra-capsular repairs .
- Medial collateral ligament -
- --Lateral collateral ligament
- Posterior oblique ligament l
Patellar realignment and tendon repairs ●
- Vastus medialis obliquous advancement
Iliotibial band tenodesis

Shoulder

Capsular stabilization .
- Bankart repair l
- Anterior shoulder instability -
- SLAP lesion repairs -
- । Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs .
Deltoid repairs .
. Rotator cuff tear repairs
. Biceps tenodesis

Foot and Ankle

Hallux valgus repairs .
Medial or lateral instability repairs/reconstructions .
Achilles tendon repairs/reconstructions .
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Flexor Hullucis Longus (FLH)
Tendon Transfers

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2/3 KO83675 >< We are smith&nephew

Elbow, Wrist, and Hand

Biceps tendon reattachment .
Ulnar or radial collateral ligament reconstructions .
Lateral epicondylitis repair .
Scapholunate ligament reconstruction .
. Tendon Transfers
Carpometacarpal Joint Arthroplasty .
Carpal Ligament Reconstruction �

G. Comparison of Technological Characteristics

The Smith & Nephew Biosure PK Interference Screw is substantially equivalent in intended use, technological characteristics, and is as safe and as effective as its currently marketed predicate devices, the Smith & Nephew BIOSURE HA Interference Screw (K080358), the Smith & Nephew BioRaptor 2.3PK (K071586) and the Arthrex Interference Screw (K062466)

H. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Biosure PK Interference Screw are substantially equivalent to the Smith & Nephew BIOSURE HA Screw, the Smith & Nephew BioRaptor 2.3PK and the Arthrex Interference Screw.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Public Health Service

JAN 30 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc., Endoscopy Division % Ms. Christina Flores 1 50 Minuteman Road Andover, Massachusetts 01810

Re: K083635

Trade/Device Name: Biosure PK Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 5, 2008 Received: December 8, 2008

Dear Ms. Flores:

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.

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.

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Page 2 - Ms. Christina Flores

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milkersen

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

Enclosure

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Indications for Use

510(k) Number (if known):

K083635

Device Name: _Smith & Nephew BIOSURE PK Interference Screws

Indications For Use:

Knee

ACL Repairs .
PCL Repairs .
Extra-capsular repairs ●
- Medial collateral ligament ।
- Lateral collateral ligament l
- Posterior oblique ligament —
Patellar realignment and tendon repairs .
- Vastus medialis obliquous advancement -
. Iliotibial band tenodesis

Shoulder

. Capsular stabilization
- Bankart repair l
- Anterior shoulder instability -
- SLAP lesion repairs -
- Capsular shift or capsulolabral reconstructions -
Acromilavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
. Biceps tenodesis

Foot and Ankle

Hallux valgus repairs .
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Flexor Hullucis Longus (FLH).

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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
Carpal Ligament Reconstruction

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Dey ice Evaluation (ODE)

(Division Sign-OFF) Division of General, Restorative, and Neurological Devices

510(k) Numbe

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

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