(85 days)
Not Found
No
The device description and intended use focus on a physical resorbable screw anchor for soft tissue reattachment, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used in soft tissue reattachment procedures to aid in healing, which falls under the definition of a therapeutic device.
No
The device is a resorbable screw anchor used for attaching soft tissue to bone during healing, indicating a therapeutic or reconstructive function rather than a diagnostic one.
No
The device description clearly indicates a physical, implantable screw anchor made of resorbable material, preloaded on a driver with suture. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for soft tissue reattachment in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implantable device (screw anchor) made of a specific material, designed to provide mechanical support. This is consistent with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.), detect biomarkers, or provide information for diagnosis.
- Performance Studies: The performance studies focus on mechanical testing and substantial equivalence to predicate surgical devices, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
In summary, the Resorbable Screw Anchor is a surgical implant used for tissue repair, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for the Resorbable Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
87MAI, HWC
Device Description
The Resorbable Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured from an 85% L-Lactide/15% Glycolide material and is available in two sizes, 3.5 mm and 5.5 mm. The screw anchor consists of a screw portion and a head portion.
The 3.5 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.5 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Resorbable Screw Anchor will be packaged sterile and will be preloaded on a driver with suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, wrist/hand, ankle/foot, elbow, 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 (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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K943806, K973775, K954443, K003273, K011522
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Page 1 of 2
NOV 2 0 2001
BIOMET
CORPORATE HEADQUARTERS
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 46581-0587 Establishment Registration No .: 1825034
Contact Person:
Sara B. Shultz Biomet Manufacturing, Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (219) 267-6639 FAX: (219) 372-1683
| Proprietary Name: | Resorbable Screw Anchor |
|---|---|
| Common or Usual Name: | resorbable screw anchor |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Product Code: | 87MAI |
Legally Marketed Devices To Which Substantial Equivalence is Claimed: Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), LactoSorb® Suture Anchor (Biomet, Inc., K954443), LactoSorb® Screw Anchor (Biomet, Inc., K003273), Resorbable Bone Pin (Biomet, Inc., K011522).
Indications for Use: Indications for the Resorbable Screw Anchor includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Image /page/0/Picture/14 description: This image shows the mailing address for an organization. The address is P.O. Box 587 in Warsaw, IN 46581-0587. The number 00241 is also present in the image, but it is unclear what it refers to.
미
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
0
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
1
page 2 of 2
Image /page/1/Picture/1 description: The image shows the logo for Biomet Inc. The logo consists of the word "BIOMET" in a stylized font, with the letters connected to each other. To the right of the word "BIOMET" is the word "INC" in a smaller font, stacked vertically. Below the logo is the text "CORPORATE HEADQUARTERS" in a smaller font.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
Device Description: The Resorbable Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured from an 85% L-Lactide/15% Glycolide material and is available in two sizes, 3.5 mm and 5.5 mm. The screw anchor consists of a screw portion and a head portion.
The 3.5 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.5 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Resorbable Screw Anchor will be packaged sterile and will be preloaded on a driver with suture.
Summary of Technologies: The Resorbable Screw Anchor's technological characteristics (materials, design, sizes, and indications) are similar to or identical 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.
Image /page/1/Picture/9 description: This image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587. The shipping address is Airport Industrial Park, Warsaw, IN 46580. The office number is 219.267.6639, the fax number is 219.267.8137, and the email address is biomet@biomet.com.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Regulatory Specialist Arthrotek, Inc. A Subsidiary of Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K012872
Ms. Sara B. Shultz
Trade/Device Name: Resorbable Screw Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: August 25, 2001 Received: August 27, 2001
Dear Ms. Shuitz:
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 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 vou 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 McMullen
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 2. 0 2001
Page
510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________
DEVICE NAME: Resorbable Screw Anchor
INDICATIONS FOR USE:
Indications for the Resorbable Screw Anchor include use in soft tissue matoutions procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
ligation: 10 Julier at stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
bloops tondon rooons. Iateral collateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
Mula N. Miller
Division of General, Restorative and Neurological Devices
510(k) Number K012872
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
h ly Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96) Nb