(81 days)
Not Found
No
The device description and intended use are purely mechanical/material-based, and there is no mention of AI, ML, image processing, or data-driven analysis.
No
The device is a suture anchor used for reattaching soft tissue to bone, which is a structural repair rather than a therapeutic treatment in itself.
No
The device description and intended use indicate it is a surgical implant designed for reattaching soft tissue to bone, not for diagnosing conditions.
No
The device description explicitly states it is a "suture anchor manufactured from PLC incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a suture anchor used for the reattachment of soft tissue to bone during surgical procedures. This is a device that is implanted within the body (in vivo) to provide mechanical support.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
The device described is a surgical implant used for orthopedic repairs, not an IVD.
N/A
Intended Use / Indications for Use
The Smith & Nephew PLC suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization Bankhart 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 instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Elbow
reconstructions Ulnar or radial collateral ligament 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
Hip
Capsular repair Acetabular labral repair
Product codes
HRS, HWC
Device Description
Preloaded 2.3 mm suture anchor manufactured from PLC incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing conducted includes bench and animal testing that demonstrates substantial equivalence to the Smith & Nephew, Inc BIORAPTOR Suture Anchor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K063726 page 1 of 2
SECTION IV MAR 06 2007 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
PLC Suture Anchor
Date Prepared: March 5, 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Deana Boushell Principal Regulatory Affairs Specialist Phone: (508) 337-4036 (508) 261-3620 FAX:
C. Device Name
| Trade Name: | PLC Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, |
| degradable, soft tissue |
D. Predicate Devices
The PLC Suture Anchor is substantially equivalent to the Smith & Nephew BioRaptor Suture Anchor (K053344).
Description of Device E.
Preloaded 2.3 mm suture anchor manufactured from PLC incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.
1
page 2 of 2
F. Indications for Use
The Smith & Nephew PLC suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization Bankhart 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 instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Elbow
reconstructions Ulnar or radial collateral ligament 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
Hip
Capsular repair Acetabular labral repair
G. Comparison of Technological Characteristics
The Smith & Nephew PLC Suture Anchor is substantially equivalent to the Smith & Nephew, Inc BIORAPTOR Suture Anchor. The only major difference is the material of the anchor which is PLC, an osteoconductive biodegradable material.
H. Summary Performance Data
The performance testing conducted includes bench and animal testing that demonstrates substantial equivalence to the Smith & Nephew, Inc BIORAPTOR Suture Anchor.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Endoscopy Division c/o Ms. Deana Boushell Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810
MAR 0 6 2007
Re: K063726
Trade/Device Name: PLC Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 14, 2006 Received: December 15, 2006
Dear Ms. Boushell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 -- Ms. Deana Boushell
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
[signature]
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko6376
§I.D
Indications for Use
510(k) Number (if known):
Device Name: PLC Suture Anchors
Indications For Use:
The Smith & Nephew PLC suture anchors are intensed for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization Bankhart 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 instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
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
Hip
Capsular repair Acetabular labral repair
Prescription Use __ x_
(Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ Yo
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Davice Evaluation (ODE)
Db. Tho
(Division Sign-Óff) (Division of General, Restorative, and Neurological Devices
510(k) Number
Page 7