The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
1. Medial or lateral instability repairs
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Tennis elbow repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament
1. Iliotibial band tenodesis
1. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
1. Medial or lateral instability repairs/reconstructions
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral epicondylitis repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:
a, medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament
1. Iliotibial band tenodesis

Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

*Pelvis:

2. Bladder neck suspension procedures

This indication is marketed separately from the orthopedic indications under the trade name Cinch®

The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist, and hand. Examples of such procedures include:

Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.

Foot and Ankle:
Hallux Valqus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.

Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.

Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Elbow: Ulnar or radial liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee: Extra-capsular repairs: - Medial collateral liqament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement Iliotibial band tenodesis

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

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

Elbow, Wrist, and Hand: Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

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

The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs

Elbow: Ulnar or radial liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee: Extra-capsular repairs: - Medial collateral ligament । - Lateral collateral ligament । - Posterior oblique ligament - Iliotibial band tenodesis Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement

Hip: Abductor tendon repair

The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Hip: Distal row abductor tendon repair.

The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankart lesion repairs 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/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Knee: Extra-capsular repairs: - Medial collateral ligament । - Lateral collateral ligament i - । Posterior oblique ligament Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement Iliotibial band tenodesis

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

Hip: Gluteal tendon repairs - -Gluteus medius and gluteus minimus repair

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

Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

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

Device Description

Smith & Nephew Non-Absorbable Suture Anchors are provided in various non-absorbable materials. All of the Smith & Nephew Non-Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a quide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for several suture anchors manufactured by Smith & Nephew. It predominantly focuses on establishing substantial equivalence to existing predicate devices, rather than detailing a study that proves a device meets specific acceptance criteria.

The document lists the product names, their intended uses (which are identical to those of the predicate devices), and states that the substantial equivalence is based on identical indications for use, design features, operational principles, material composition, and performance to the predicate devices. It also mentions "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices."

However, the document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study design that proves a device meets those criteria. The provided text is a regulatory clearance document, not a clinical study report or a detailed engineering test report.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: The document states that the anchors "are substantially equivalent" in performance, but it doesn't provide a table of quantitative acceptance criteria (e.g., minimum pullout strength in Newtons) or the specific measured performance values for the new devices and predicates.
Sample size used for the test set and the data provenance: While "Ship Testing and Post-Shipment mechanical functional testing" is mentioned, the sample sizes, type of data (e.g., in-vitro, ex-vivo), or provenance (country of origin, retrospective/prospective) are not detailed.
Number of experts used to establish the ground truth for the test set and their qualifications: This type of information is typically related to clinical image interpretation or diagnosis studies, not mechanical testing of implants. There's no mention of experts establishing a "ground truth" in this context.
Adjudication method for the test set: Not applicable as there's no mention of expert review or clinical assessment.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted image interpretation studies, not mechanical device clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): In the context of mechanical testing mentioned, the "ground truth" would be the measured physical properties (e.g., force, displacement), but the document does not specify the methods or a reference standard in detail.
The sample size for the training set: Not applicable, as there's no machine learning algorithm involved.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter for a medical device based on substantial equivalence to predicate devices, and as such, it does not contain the detailed study design and results (acceptance criteria, sample sizes, ground truth establishment, expert involvement, etc.) typically found in a clinical or performance study report. The statement "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices" is the extent of the performance data provided, without specific numerical detail or study methodology.

Summary

{0}------------------------------------------------

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

December 2, 2015

Smith & Nephew, Incorporated Katherine Marcaccio Regulatory Affairs Specialist II 130 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K152566

Trade/Device Name: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra PK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 9, 2015 Received: September 10, 2015

Dear Katherine Marcaccio:

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.

{1}------------------------------------------------

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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152566

Device Name PEBA Anchor/Suture Combination

Indications for Use (Describe)

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of nonabsorbable synthetic sutures.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
1. Medial or lateral instability repairs
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Tennis elbow repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament
1. Iliotibial band tenodesis
1. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740 EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

{4}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152566

Device Name

2.0mm Mini-Tac Anchor, Model 10-1629-01

Indications for Use (Describe)

The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
1. Medial or lateral instability repairs/reconstructions
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral epicondylitis repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament
1. Iliotibial band tenodesis
1. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

*Pelvis:

1. Bladder neck suspension procedures
- This indication is marketed separately from the orthopedic indications under the trade name Cinch®

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{5}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{6}------------------------------------------------

Indications for Use

510(k) Number (if known) K152566

Device Name Modification to Twinfix Ti Quick T

Indications for Use (Describe)

The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, wrist, and hand. Examples of such procedures include:

Shoulder:

Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular sepairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.

Foot and Ankle:

Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.

Elbow, Wrist and Hand:

Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.

Knee:

Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

{7}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{8}------------------------------------------------

Indications for Use

510(k) Number (if known) K152566

Device Name Twinfix FT PK

Indications for Use (Describe) The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

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

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{9}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{10}------------------------------------------------

Indications for Use

510(k) Number (if known) K152566

Device Name

Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors

Indications for Use (Describe)

The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs

Elbow:

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

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

Hip:

Abductor tendon repair

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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{11}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{12}------------------------------------------------

Indications for Use

510(k) Number (if known) K152566

Device Name FOOTPRINT Ultra PK Suture Anchors

Indications for Use (Describe) The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Hip: Hip capsular repair -Acetabular labral repair

Shoulder: Capsular Stabilization - Bankart Repair -Anterior Shoulder Instability Repair -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 Elbow, Wrist, and Hand: Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

Knee:

Extra-capsular repairs: -medial collateral ligament -lateral collateral ligament -posterior oblique ligament Patellar realignment and tendon repairs: -vastus medialis obliquous advancement lliotibial band tenodesis

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{13}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{14}------------------------------------------------

Indications for Use

510(k) Number (if known)

K152566

Device Name

BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor

Indications for Use (Describe)

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 Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

{15}------------------------------------------------

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{16}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152566

Device Name

HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor)

Indications for Use (Describe)

The Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

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:

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

Hip:

Gluteal tendon repairs - Gluteus medius and gluteus minimus repair

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

{17}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{18}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152566

Device Name

Bioraptor Curved 2.3 PK Suture Anchors

Indications for Use (Describe) The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

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

Elbow, Wrist, and Hand: Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

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

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Advanced Surgical Devices Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

T 978 749 1000 F 978 749 1599 www.smith-nephew.com

Image /page/20/Picture/3 description: The image contains the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text is in a combination of gray and orange, with "smith&nephew" in orange.

510(k) Summary 2015

Date Prepared: November 9,

Submitter Information	Contact Information
Smith & Nephew, Inc.150 Minuteman RoadAndover, MA 01810	Katherine Marcaccio
	Regulatory Affairs Specialist II
	Phone: (508) 261-3602Fax: (978) 749-1443

Device Name (Unmodified)
Trade or proprietary name	Smith & Nephew Non-Absorbable Suture Anchors
Common or usual name	MBI - Fastener, Fixation, Nondegradable, Soft Tissue
Classification name	21 CFR §888.3040 – Smooth or threaded metallic bonefixation fastener

Legally Marketed Predicate Device

The Smith & Nephew Non-Absorbable Suture Anchors are substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

510(k)Number	Device Name	ClearanceDate
K972326	PEBA ANCHOR/SUTURE COMBINATION	02/06/1998
K000797	2.0mm MINI-TAC ANCHOR, MODEL 10-1629-01	04/03/2000
K023021	MODIFICATION TO SMITH & NEPHEW TWINFIX TIQUICK-T	10/04/2002
K072785	Twinfix FT PK	12/10/2007
K102660	BIORAPTOR CURVED 2.3 PK Suture Anchors	12/13/2010
K112526	TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIXULTRA HA Suture Anchors	01/31/2012
K113274	FOOTPRINT Ultra PK suture anchors	03/06/2012
K113294	SMITH & NEPHEW Healicoil PK Suture Anchor	01/20/2012
K121018	Smith & Nephew, Inc. BIORAPTOR 2.9 Suture Anchor,BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTORSuture Anchor, BIORAPTOR Knotless Suture Anchor	06/22/2012

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Image /page/21/Picture/1 description: The image shows the logo for Smith & Nephew. The logo features an orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.

Intended Use

Smith & Nephew Suture Anchors - PEBA Anchor/Suture Combination This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral
reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
1. Medial or lateral instability repairs
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon
repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament
reconstructions
1. Ulnar or radial collateral ligament
reconstructions
1. Tennis elbow repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
1. Iliotibial band tenodesis
1. Patellar realignment and tendon repairs, including vastus medialis
obliquous advancement

Smith & Nephew Suture Anchors – 2.0mm MINI-TAC ANCHOR, MODEL 10-1629-01 The OBL Preloaded Series Anchor is intended for use only for the fixation of non-

absorbable synthetic suture material for the following indications:

Shoulder:

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1. Bankart lesion repairs
1. SLAP lesion repairs
1. Acromio-clavicular separation repairs
1. Rotator cuff tear repairs
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
1. Medial or lateral instability repairs/reconstructions
1. Achilles tendon repairs/reconstructions
1. Midfoot reconstructions
1. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
1. Ulnar or radial collateral ligament reconstructions
1. Lateral epicondylitis repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:
- a, medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
1. Iliotibial band tenodesis

Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

*Pelvis:

1. Bladder neck suspension procedures

This indication is marketed separately from the orthopedic indications under the trade name Cinch®

Smith & Nephew Suture Anchors – Modification to Twinfix Ti Quick T

Shoulder:

Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.

Foot and Ankle:

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Image /page/23/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.

Hallux Valqus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.

Elbow, Wrist and Hand:

Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.

Knee:

Smith & Nephew Suture Anchors – Twinfix FT PK

The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle:

Hallux valgus repairs

Elbow:

Ulnar or radial collateral liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee:

Extra-capsular repairs:

Medial collateral liqament -
Lateral collateral ligament -
Posterior oblique ligament -

Patellar realignment and tendon

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Image /page/24/Picture/1 description: The image shows the logo for Smith & Nephew. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.

Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

repairs:

-Vastus medialis obliquous advancement Iliotibial band tenodesis

Smith & Nephew Suture Anchors - Bioraptor Curved 2.3 PK Suture Anchors The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

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

Elbow, Wrist, and Hand:

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

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

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Image /page/25/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the words "smith&nephew" are written in orange.

repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Smith & Nephew Suture Anchors - Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors

The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs

Foot and Ankle:

Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Elbow:

Ulnar or radial collateral liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee:

Extra-capsular repairs:

Medial collateral ligament ।
Lateral collateral ligament ।
Posterior oblique ligament -

Iliotibial band tenodesis Patellar realignment and tendon repairs:

Vastus medialis obliquous advancement

Hip:

Abductor tendon repair

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Image /page/26/Picture/1 description: The image contains the logo for Smith & Nephew. The logo features an orange flower-like symbol on the left. To the right of the symbol is the text "We are smith&nephew", with "We are" in gray and "smith&nephew" in orange.

Smith & Nephew Suture Anchors – FOOTPRINT Ultra PK Suture Anchors

The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Hip: Distal row abductor tendon repair.

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Image /page/27/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange, matching the color of the flower symbol.

Smith & Nephew Suture Anchors - HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor)

Shoulder:

Bankart lesion repairs 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/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Knee:

Extra-capsular repairs:

Medial collateral ligament ।
Lateral collateral ligament i
। Posterior oblique ligament

Patellar realignment and tendon repairs:

Vastus medialis obliquous advancement Iliotibial band tenodesis

Elbow:

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

Hip:

Gluteal tendon repairs

-Gluteus medius and gluteus minimus repair

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Image /page/28/Picture/1 description: The image contains the Smith & Nephew logo. The logo features an orange flower-like symbol on the left. To the right of the symbol, the text "We are smith&nephew" is displayed, with "We are" in gray and "smith&nephew" in orange.

Smith & Nephew Suture Anchors - BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor

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
Technological Characteristics

Elbow, Wrist, and Hand

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

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

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Image /page/29/Picture/1 description: The image contains the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the words "smith&nephew" are written in orange. The logo is simple and modern.

Smith & Nephew Non-Absorbable Suture Anchors are substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices in this submission and raises no new issues of safety and efficacy.

Summary of Performance Data

Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices.

Substantial Equivalence Information

The substantial equivalence of the Non-Absorbable Suture Anchors is based on identical indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the identical features to the predicates, the Non-Absorbable Suture Anchors are substantially equivalent to the predicates.

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.