The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Hip: Hip capsule repair - Acetabular labrum reattachment/reconstruction Shoulder: Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff 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 Knee: Extra-capsular repairs - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis Elbow, Wrist, and Hand: Lateral epicondylitis repair Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions

Device Description

Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.

AI/ML Overview

The provided document is a 510(k) summary for Smith & Nephew suture anchors, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a new study with performance metrics.

Therefore, many of the requested sections related to acceptance criteria, device performance from a test set, expert involvement, and ground truth are not explicitly available in the provided text. The submission relies on the prior clearances and the inherent characteristics of the device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that "Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence." This implies that the acceptance criteria for these mechanical properties were met in the original clearances of the predicate devices, and because there have been no changes to the design or materials, they are still considered met.

Acceptance Criteria (Implied from Predicate Devices)	Reported Device Performance (Implied from Predicate Devices)
Sufficient insertion strength	Met (based on prior clearances of predicate devices)
Sufficient pull-out strength	Met (based on prior clearances of predicate devices)
Acceptable suture sliding characteristics	Met (based on prior clearances of predicate devices)
No significant changes in design or materials compared to predicate devices	Confirmed: "There have been no major changes in design or materials..."
No additional risk introduced by expanded indication (acetabular labrum reconstruction)	Confirmed: "...the expansion of indications for use to include labral reconstruction introduces no additional risk..."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission doesn't describe a new study with a "test set" for performance evaluation in the context of diagnostic accuracy or a similar measurable outcome. The "test set" implicitly refers to the mechanical testing performed for the original clearances of the predicate devices. The document does not provide details on the sample sizes or data provenance (country of origin, retrospective/prospective nature) of these original mechanical tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. There is no mention of experts establishing a "ground truth" for a test set in this 510(k) submission. The evaluation is based on mechanical properties and substantial equivalence to previously cleared devices.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described for a test set in this submission.

5. 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 is a medical device for surgical procedures (suture anchors), not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (suture anchors) is established through mechanical testing (e.g., measuring forces required for insertion, pull-out, and suture sliding) against engineering specifications and industry standards, and ultimately, through clinical outcomes data from the use of the device and its predicates. The submission references reliance on "mechanical testing" for the predicate devices and "published articles supporting the additional indication," suggesting that the clinical effectiveness and safety of such devices are established in the medical literature.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/machine learning device.

Summary

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K121018(1/3)

JUN 2 2 2 2012

510(k) Summary Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® PK 2.3, OSTEORAPTOR®, and BIORAPTOR® Knotless Suture Anchors

Submitted by:	Smith & Nephew, Inc.150 Minuteman RoadAndover, MA 01810
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Date of Summary:	April 3, 2012
Contact Person and Address:	John Connor, Regulatory Affairs SpecialistT (901) 399-5944 F (901) 566-7961
Name of Device(s):	Smith & Nephew, Inc. BIORAPTOR® 2.9 Suture AnchorSmith & Nephew, Inc. BIORAPTOR® 2.3 PK SutureAnchorSmith & Nephew, Inc OSTEORAPTOR® Suture AnchorSmith & Nephew, Inc. BIORAPTOR® Knotless SutureAnchor
Common Name:	Fastener, Fixation, Biodegradable, Soft TissueFastener, Fixation, Nondegradable, Soft Tissue
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	MAI, MBI

Device Description

Technological Characteristics

There have been no major changes in design or materials in the subject suture anchors since their market clearance. As such, the technological characteristics of the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK OSTEORAPTOR®, and BIORAPTOR® Knotless Suture Anchors have not changed.

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KI21018(
$$^{2}/_{3}$$
)

Intended Use

The Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors are intended for use in the attachment or reattachment of soft tissue to bone for the following indications:

Hip

Hip capsule repair (Acetabular labrum reattachment/reconstruction)

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 repair/reconstructions, Bunionectomy

Elbow, Wrist, and Hand

Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

Knee

Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis

Substantial Equivalence Information

The substantial equivalence of the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors is based on similarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below. As there have been no significant changes to the design of the subject suture anchors, and the expansion of indications for use to include labral reconstruction introduces no additional risk, Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	BIORAPTOR® 2.9 Suture Anchors	K053344	02/23/2006
Smith & Nephew, Inc.	BIORAPTOR® 2.3 PK Suture Anchors	K071586	08/17/2007
Smith & Nephew, Inc.	OSTEORAPTOR® Suture Anchors	K082215	11/03/2008
Smith & Nephew, Inc.	BIORAPTOR® Knotless Suture Anchors	K093428	12/17/2009

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KI21018(3/3)

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to expand the indications for use for the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. Based on the similarities to the predicate components and published articles supporting the additional indication, the devices are substantially equivalent to their predicates.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, and a wavy line representing its tail.

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

JUN 2 2 2012

Smith and Nephew, Inc. % Mr. John Connor 7135 Goodlett Farms Parkway Cordova, Tennesee 38016

Re: K121018

Trade/Device Name: BIORAPTOR™ 2.9, BIORAPTOR™ 2.3 PK, OSTEORAPTOR™, and BIORAPTOR™ Knotless Suture Anchors

Regulation Number: 21 CFR 888.3040

Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: April 3, 2012 Received: April 4, 2012

Dear Mr. Connor:

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 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); medical device reporting (reporting of medical

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Page 2 - Mr. John Connor

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,
Eil Keith

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

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): _ K121018

Device Name:

BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors

Indications for Use:

The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

Hip

Hip capsule repair

Acetabular labrum .
- reattachment/reconstruction

Shoulder

Capsular stabilization

. Bankart repair
Anterior shoulder instability .
SLAP lesion repairs .
Capsular shift or capsulolabral . reconstructions

Acromioclavicular separation repairs Deltoid repairs

Rotator Cuff 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

Knee

Extra-capsular repairs

reconstructions

Elbow, Wrist, and Hand

Lateral epicondylitis repair

Biceps tendon reattachment

Ulnar or radial collateral ligament

Medial collateral ligament .
Lateral collateral ligament .
Posterior oblique ligament .

Patellar realignment and tendon repairs

Vastus medialis obliquous ● advancement
Iliotibial band tenodesis

Ast

(Division 'lign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K121018 510(k) Number

AND/OR Prescription Use __ X (Part 21 CFR 801.109) l

Over-the-Counter Use _ (Optional Format 1-2-96)

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.