(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a resorbable suture anchor and suture, with no mention of AI or ML.
No.
The device description and intended use clearly state that it is a resorbable suture anchor used to reattach soft tissue to bone, which is a surgical implant rather than a therapeutic device that delivers therapy or treatment in a broader sense (e.g., drug delivery, radiation therapy, or electrical stimulation).
No.
The device is a surgical implant designed for soft tissue reattachment, not for diagnosis.
No
The device description clearly describes a physical, resorbable suture anchor and suture, which are hardware components. There is no mention of any software functionality.
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 reattaching soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a resorbable screw anchor and suture, which are physical components used in surgery. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a surgical implant used for repair and reconstruction, falling under the category of medical devices used for treatment rather than diagnosis.
N/A
Intended Use / Indications for Use
Indications for the LactoSorb® Screw Anchor with Lactocarbonate Suture includes the 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 econstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique repair, joint capsule closure, illotibial band tenodesis, and patellar ligament/tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The LactoSorb® Screw Anchor's are resorbable suture anchors used to reattach soft tissue to bone. The anchors consist of a screw portion and a head portion engages with the bone while the head portion provides a means to drive the anchor into the bone.
Lactocarbonate Suture, undyed (white) or dyed (violet), is a synthetic resorbable sterile surgical suture. The suture is a braided size 2 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: Nonclinical laboratory testing was performed to determine substantial equivalence. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of Lactocarbonate suture (L-lactide / trimethylene carbonate, dyed and undyed. Results indicated that the device was highly biocompatible and was functional within its indicated uses.
Clinical Testing: None provided as a basis for substantial equivalence.
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.
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
OCT = 1 2003
Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is written in large, bold, block letters. Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
510(k) Summary
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel
Telephone: (574) 267-6639
Fax: (574) 372-1683 |
| Proprietary Name: | LactoSorb® Screw Anchor with Lactocarbonate Suture |
| Common Name: | Resorbable Suture and Screw |
| Classification Name: | Fastener, Fixation, Biodegradable Soft tissue; 87 MAI |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Biomet's LactoSorb® L15 Screw Anchor (K012872), Ethicon's Mitek Panalok Suture Anchor System (K970396), and Biomet's LactoSorb® L18 Screw Anchor (K003273).
Device Description:
The LactoSorb® Screw Anchor's are resorbable suture anchors used to reattach soft tissue to bone. The anchors consist of a screw portion and a head portion engages with the bone while the head portion provides a means to drive the anchor into the bone.
Lactocarbonate Suture, undyed (white) or dyed (violet), is a synthetic resorbable sterile surgical suture. The suture is a braided size 2 suture.
Intended Use:
Indications for the LactoSorb® Screw Anchor with Lactocarbonate Suture includes the 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 econstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique repair, joint capsule closure, illotibial band tenodesis, and patellar ligament/tendon repair.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
I
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
이
( )FFICE 574.267.6639
FAX 574.267.8137
II.-MAIL biomet@biomet.com
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Page 242
510(k) Summary LactoScrb® Screw Anchor with Lactocarbonate Suture E iomet, Inc. F age 2
Summary of Technologies:
™ he technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices.
Non-Clinical Testing: Nonclinical laboratory testing was performed to determine substantial • quivalence. Biocompatibility and Functionality testing was conducted to assess the safety and >ffectiveness of Lactocarbonate suture (L-lactide / trimethylene carbonate, dyed and undyed. Results ndicated that the device was highly biocompatible and was functional within its indicated uses.
Clinical Testing: None provided as a basis for substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
OCT - 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrotek, Inc. c/o Ms. Tracy J. Bickel Regulatory Associate Biomet Orthopedic, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K032072
Trade/Device Name: LactoSorb® L15 Screw Anchor with Lactocarbonate Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 1, 2003 Received: July 3, 2003
Dear Ms. Bickel:
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. Tracy J. Bickel
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. Millenson
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
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Page 1 of 1
510(k) Number (if known): Device Name: LactoSorb® Screw Anchor with Lactocarbonate Suture Indications for Use:
I ndications for the LactoSorb® Screw Anchor with Lactocarbonate Suture includes the u se 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, ulnat/radial collateral ligament reconstruction.
stabilization, medial stabilization, Ankle/Foot: Lateral 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 repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
for Mark N. Milliken
(Division Sign-Off)
Division of Ger end, Restorative and Neurological Devices
510(k) Number K032072
(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 No
(Optional Format 1-2-96)