(37 days)
No
The device description and intended use are for a mechanical suture anchor made of PEEK plastic, with no mention of any computational or analytical capabilities that would involve AI/ML.
Yes
The device aids in soft tissue reattachment, which is a therapeutic intervention for various injuries and conditions in the musculoskeletal system.
No
The device is a suture anchor, which is used for soft tissue reattachment procedures. It is a surgical implant, not a tool for diagnosis.
No
The device description clearly states it is a physical screw-like anchor made of PEEK plastic, supplied with sutures, taps, and guides. This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical implant used for reattaching soft tissue to bone in various anatomical locations (shoulder, elbow, wrist/hand, foot/ankle, and knee). This is a direct surgical intervention on the body.
- Device Description: The device is described as a screw-like implant made of PEEK plastic with associated sutures and instruments for implantation. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted inside the body for therapeutic purposes.
N/A
Intended Use / Indications for 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, 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 RoGTM 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.
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, elbow, wrist/hand, foot/ankle and knee.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance characteristics of the anchors have not changed from those described in K111590. Sutures supplied with the device meet the requirements of the U.S. Pharmacopeia for non-absorbable suture as well as all requirements of Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003".
Key Metrics
Not Found
Predicate Device(s)
K111590 - RoGTM Suture Anchor
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) SUMMARY
Premarket Notification: K113299
December 8, 2011
DEVICE: RoGTM 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: 3009227834
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):
K111590 - RoGTM Suture Anchor
DESCRIPTION OF SUBJECT DEVICE:
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.
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.
1
- . 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 RoGTM 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 changed from those described in K111590. Sutures supplied with the device meet the requirements of the U.S. Pharmacopeia for non-absorbable suture as well as all requirements of Class II Special
2|Page
K113299
2
Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003".
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. 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. The proposed modification consists solely of extending the current expiration date. Testing has shown the anchor, suture and packaging to be stable for the proposed period.
3 | Page
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol. The logo is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RoG Sports Medicine, Incorporated % Orchid Design Mr. Curtis Raymond Senior Regulatory & Quality Consultant 1640 South 104th Avenue Orland Park, Illinois 60467
DEC 1 5 2011
Re: K113299
Trade/Device Name: RoGTM Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 7, 2011 Received: November 16, 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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Curtis Raymond
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.
があるない時間の良かないではないです。 そしてく、となれば、 に、は、は、 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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,
M. Krum
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K113297 (1/2)
Page 1 of 2
Indications for Use
510(k) Number (if known): K
Device Name: RoGTM 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
- 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 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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)
Michael Ques for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, I and Restorative Devices
510(k) Number