(116 days)
Not Found
No
The summary describes a mechanical resorbable screw and washer assembly for soft tissue reattachment and does not mention any AI/ML components or functionalities.
No.
The device is described as a resorbable screw and washer assembly for soft tissue reattachment, and its intended use is to repair injuries through surgical means, which are structural interventions rather than therapeutic treatments.
No
Explanation: The device is a resorbable screw and washer assembly preloaded with suture, indicated for various surgical repairs of ligaments and tendons in multiple anatomical sites. Its function is to facilitate repair, not to diagnose medical conditions.
No
The device description clearly states it is a "resorbable screw and washer assembly," which are physical hardware components, not software.
Based on the provided information, 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.
- Device Description and Intended Use: The description clearly states the device is a resorbable screw and washer assembly used for the surgical repair and reattachment of soft tissue in various joints (shoulder, wrist, elbow, knee). This is a surgical implant used within the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or any other activity typically associated with IVDs.
Therefore, this device falls under the category of a surgical implant or device used in surgical procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist Indications: Scapholunate ligament reconstruction.
Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee Indications: Extra-capsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
The Soft Tissue Screw and Washer is preloaded with suture for use at the discretion of the physician.
Product codes
87MAI, HWC, HTN
Device Description
The device is a resorbable screw and washer assembly. The screw measures 12.5mm in length and 2.25mm in diameter. The washer is oval shaped and measures 7mm along the long axis with two spikes to hold the soft tissue in place. The device is fully cannulated to accommodate the driver mechanism. The device may be used with any legally marketed suture (size 1 or 2) for secondary reattachment of soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Wrist, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973775, K931519, K011522, K953877, 510(k) number unknown
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
K012572/51
page 1 of 2
DEC 03 2001
CORPORAT ARTERS
SUMMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Arthrotek, Inc.
(A wholly owned subsidiary of Biomet, Inc.)
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0578
Establishment Registration No.:1825034 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sara B. Shultz
Biomet Manufacturing, Corp.
P.O. Box 587
Warsaw, Indiana 46581-0578
Phone: (219) 267-6639
FAX: (219) 372-1683 |
| Proprietary Name: | Soft Tissue Screw and Washer |
| Common or Usual Name: | resorbable screw and washer |
| Classification Name: | Fastener, Fixation, Biodegradable soft tissue |
| Device Product Code: | 87MAI |
Legally Marketed Devices To Which Substantial Equivalence is Claimed: Mini Harpoon® Suture Anchor (Biomet, Inc., K973775), Acufex's Suretac® (Acufex, K931519), Resorbable Bone Pin (Biomet, Inc., K011522), Mitek Gll Anchor (Mitek Surgical Products, Inc., K953877), Quick Anchor Plus (Mitek Surgical Products, Inc., 510(k) number unknown).
Indications for Screw and Washer:
Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist Indications: Scapholunate ligament reconstruction.
Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
.
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
1
K01257251
page 2 of 2
Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, black letters. Below that, the words "CORPORATE HEADQUARTERS" are in smaller, thinner, black letters.
Knee Indications: Extra-capsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
This product is preloaded with suture for use at the discretion of the physician.
Device Description: The device is a resorbable screw and washer assembly. The screw measures 12.5mm in length and 2.25mm in diameter. The washer is oval shaped and measures 7mm along the long axis with two spikes to hold the soft tissue in place. The device is fully cannulated to accommodate the driver mechanism. The device may be used with any legally marketed suture (size 1 or 2) for secondary reattachment of soft tissue.
Summary of Technologies: The Soft Tissue Screw and Washer technological characteristics (material and design) are similar to the predicate devices.
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
0
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
트
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K012572
Trade/Device Name: Soft Tissue Screw and Washer Regulation Number: 888.3040, 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC, HTN Dated: October 24, 2001 Received: October 25, 2001
Dear Ms. Shultz:
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 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.
3
Page 2 - Ms. Sara B. Shultz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Mark N Milbersm
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
K012572 S1
Page _ of _.
kol2572 510(k) NUMBER (IF KNOWN):_
DEVICE NAME: Soft Tissue Screw and Washer
INDICATIONS FOR USE:
Indications for Screw and Washer:
Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist Indications: Scapholunate ligament reconstruction.
Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee Indications: Extra-capsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
The Soft Tissue Screw and Washer is preloaded with suture for use at the discretion of the physician.
(PLEASE DO NOT 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)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Mark M
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_