(21 days)
No
The device description is for a physical suture anchor and the summary does not mention any software, algorithms, or data processing capabilities.
No.
The device is a bioabsorbable anchor with sutures that reattaches soft tissue to bone; it is used in surgical repair procedures, not for therapy.
No
The provided text describes a bioabsorbable anchor used for surgical reattachment of soft tissue to bone. Its intended use is for various repair and reconstruction procedures, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly states it is a "bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached," indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The provided information describes a surgical anchor used to reattach soft tissue to bone within the body. It's a physical implant used during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on bodily fluids or tissues.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Twin Fix AB 6.5 mm anchor is a bioabsorable suture anchor utilized for the reattachment of soft tissue to bone.
The indications for the Twin Fix AB 6.5 mm anchor are:
Shoulder:
-
- Bankart Lesion Repair
-
- Slap Lesion Reapir
-
- Acromioclavicular separation repairs
-
- Rotator Cuff Repair
-
- Capsular shift or capsulolabral reconstruction
-
- Biceps tenodesis
-
- Deltoid Repair
Foot and Ankle:
-
- Hallux Valgus repair
-
- Medial or Lateral instability repairs/reconstruction
-
- Achilles tendon repair/reconstruction
-
- Midfoot reconstruction
-
- Metatarsal ligament/tendon repairs/reconstruction
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstruction
-
- Ulnar or radial collateral ligament reconstruction
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular Repairs:
- Medial Collateral Repair 1a.
- 1b. Lateral Collateral Ligament
- Posterior Oblique Ligament 1c.
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquos advancement
Product codes
MAI
Device Description
The Twin Fix AB 6.5 mm anchor is a bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist, Hand, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
K032197 PMGL 1/2
AUG - 8 2003
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: (978) 749-1000 Toll Free: 1-800-343-8386 Fax: (978) 749-1599
Smith@Nephew
SECTION V 510(k) Summary
Twin Fix AB™ 6.5 mm suture anchor
Date Prepared: June 15, 2003
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
A. Submitter
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 508. 261.3699
B. Company Contact
Jason Bilobram Regulatory Affairs Manager
C. Device Name
| Trade Name: | Twin Fix AB 6.5 mm anchor |
|---|---|
| Common Name: | Absorbable Suture Anchor |
| Classification Name: | Class II, Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code MAI | |
| D. Predicate Devices | 5.0 mm Absorbable Polymer Anchor (K011299) |
| Proprietary Name: Twin Fix AB 5.0 mm suture anchor |
E. Description of Device
The Twin Fix AB 6.5 mm anchor is a bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached.
1
F. Intended Use
The Twin Fix AB 6.5 mm anchor is a bioabsorable suture anchor utilized for the reattachment of soft tissue to bone.
The indications for the Twin Fix AB 6.5 mm anchor are:
Shoulder:
-
- Bankart Lesion Repair
-
- Slap Lesion Reapir
-
- Acromioclavicular separation repairs
-
- Rotator Cuff Repair
-
- Capsular shift or capsulolabral reconstruction
-
- Biceps tenodesis
-
- Deltoid Repair
Foot and Ankle:
-
- Hallux Valgus repair
-
- Medial or Lateral instability repairs/reconstruction
-
- Achilles tendon repair/reconstruction
-
- Midfoot reconstruction
-
- Metatarsal ligament/tendon repairs/reconstruction
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstruction
-
- Ulnar or radial collateral ligament reconstruction
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular Repairs:
- Medial Collateral Repair 1a.
- 1b. Lateral Collateral Ligament
- Posterior Oblique Ligament 1c.
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquos advancement
G. Comparison of Technological Characteristics
The Twin Fix AB 6.5 mm anchor is identical in design, operating principle, material and intended use to the Twin Fix AB 5.0 mm anchor.
foan Bilah
n Bilobram las Regulatory Affairs Manager
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a symbol that looks like three stylized waves or lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Mr. Jason Bilobram Regulatory Affairs Manager Smith & Nephew, Inc. Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K032197
Trade Name: Twin Fix AB™ 6.5mm Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: July 17, 2003 Received: July 18, 2003
Dear Mr. Bilobram:
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 - Mr. Jason Bilobram
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name: 6.5 mm Absorbable Polymer Anchor
(Proprietary Name) Twin Fix™ AB 6.5 mm anchor
Intended Use: Reattachment of soft tissue to bone
Indications for Use:
Shoulder:
- Bankart Lesion Repair 1.
- SLAP Lesion Repair 2.
- Acromioclavicular separation repairs 3.
- Rotator Cuff Repair 4.
- Capsular shift or capsulolabral reconstruction ട്.
- Biceps tenodesis 6.
- Deltoid Repair 7.
Foot and Ankle:
- Hallux Valgus repair 1.
- Medial or Lateral instability repairs/reconstruction 2.
- Achilles tendon repair/reconstruction 3.
- Midfoot reconstruction 4.
- Metatarsal ligament/tendon repairs/reconstruction 5.
Elbow, Wrist, and Hand:
- Scapholunate ligament reconstruction 1.
- Ulnar or radial collateral ligament reconstruction 2.
- Lateral epicondylitis repair 3.
- Biceps tendon reattachment 4.
Knee:
- Extra-capsular Repairs: 1.
- Medial Collateral Repair la.
- 1b. Lateral Collateral Ligament
- Posterior Oblique Ligament 1c.
-
- Iliotibial band tenodesis
- Patellar realignment and tendon repairs, including vastus medialis obliquos advancement 3.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) Over-the-Counter
Division of General, Re ptional Format 1-2-96) and Neurological De
(03219 510(k) Number.