The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

. Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction. . scapholunate ligament reconstruction.
. Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications:- Scapholunate ligament reconstruction. .
Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
. Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. Iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

Shoulder indications:- Bankart repair. rotator cuff repair. SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
. Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction. scapholunate ligament reconstruction.
Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral ● ligament reconstruction, lateral epicondylitis repair.
Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

Device Description

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

AI/ML Overview

This document is a 510(k) Summary for the RoG Sports Medicine Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed performance studies or specific acceptance criteria for a new AI/software device. Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text.

The document states: "Performance characteristics of the anchors have not changes from those described in K110229 and L110230. The only changes to the device are supplying the device with non-absorbable suture and pre-sterilized."

This indicates that the current submission (K111590) is for a modified version of an already cleared device, and thus, extensive new performance studies (especially those involving AI or software as typically implied by your request) are not part of this particular submission. The focus is on demonstrating that the modifications (suture type and sterilization method) do not alter the substantial equivalence to the predicate devices.

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance: This is not present as the device itself hasn't undergone new performance testing for this submission. The "performance characteristics" are stated to be unchanged from predicate devices.
Sample size used for the test set and the data provenance: Not applicable for a non-AI/software device submission of this nature.
Number of experts used to establish the ground truth...: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as there is no algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The "Safety Characteristics" section mentions compliance with ISO 10993 (biocompatibility) and ISO 11135-1 (sterilization), but these are standards for material safety and manufacturing processes, not specific performance criteria for the device's functional use in the way described in your request for AI/software.

Summary

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KIII 590 (113)

AUG - 8 2011

510(k) SUMMARY

June 4, 2011

DEVICE: RoG Sports Medicine Suture Anchor

SPONSOR/MANUFACTURER:

RoG Sports Medicine, Inc. 16450 S. 104th Ave. Orland Park, IL 60467

SUMBITTER/REGULATORY CONTACT:

Curtis Raymond Orchid Design -80 Shelton Technology Ctr. Shelton, CT 06484

FDA ESTABLISHMENT REGISTRATION NUMBER: (pending)

TRADE NAME, COMMON NAME, CLASSIFICATION:

TRADE NAME: Modified RoGTM Suture Anchor

COMMON NAME: Suture Anchor

CLASSIFICATION: Class II (ref.: 21 CFR 888.3040); Product Code MBI

PREDICATE DEVICE(S):

K110229 RoGTM Suture Anchor ●
K110230 RoG™ Knotless Suture Anchor ●

DESCRIPTION OF SUBJECT DEVICE:

INTENDED USE:

The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

. Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications :- Ulnar/Radial collateral ligament reconstruction, ●

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

人

scapholunate ligament reconstruction.

. Foot/Hand indications:- Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair. illiotibial band tenodesis, joint capsule closure.

The RoG™ 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

Shoulder indications :- Bankart repair, rotator cuff repair, SLAP lesion repair, . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
. Wrist/hand indications:- Scapholunate ligament reconstruction.
Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
· · Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. illotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG™ 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

. Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
. Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
. Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
. Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

PERFORMANCE CHARACTERISTICS:

Performance characteristics of the anchors have not changes from those described inK110229 and L110230. The only changes to the device are supplying the device with non-absorbable suture and pre-sterilized. Sutures supplied with the device meet the requirements of the U.S. Pharmacopeia for non-absorbable suture.

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K 111 290 (313)

SAFETY CHARACTERISTICS:

The device is composed exclusively of polyetheretherketone (PEEK). A Master File demonstrating safety of the material has been supplied by the PEEK supplier and shows compliance to the requirements of ISO 10993. Sterilization of the device is in compliance with ISO 11135-1. Sterilant residues are within the limits of ISO 10993-7.

CONCLUSION(S):

The subject device has the same design considerations, assembly configurations, performance characteristics and indications for use as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.

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

RoG Sports Medicine, Inc. % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, Connecticut 06484

AUG - 8 2011

Re: K111590

Trade/Device Name: RoG™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: August 3, 2011 Received: August 4, 2011

Dear Mr. Raymond:

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 (21

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

Page 2 - Mr. Curtis Raymond

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 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/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 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,

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

Enclosure

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K 11159.0 (1/2)

Page 1 of 2

Indications for Use

510(k) Number (if known): K

Device Name: RoG™ Suture Anchor

The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

. Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction. . scapholunate ligament reconstruction.
. Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/hand indications:- Scapholunate ligament reconstruction. .
Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
. Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. Iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

Shoulder indications:- Bankart repair. rotator cuff repair. SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
. Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction. scapholunate ligament reconstruction.

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

K 11159$\alpha$(2/2)

Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral ● ligament reconstruction, lateral epicondylitis repair.
Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-(){f) (Division of Surgical, Orthopedic, and Restorative Devices

/// 570

510(k) Number

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.