(42 days)
No
The summary describes a resorbable suture anchor and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The indications for use describe repair and reconstruction of soft tissues (ligaments, tendons, capsules, and muscles) using the suture anchor, which is a structural device, not a therapeutic agent.
No
Explanation: The device description indicates that the Hitch™ LactoSorb® Suture Anchor is an implantable device used for soft tissue reattachment procedures (e.g., Bankart repair, rotator cuff repair). It describes the material and how it's inserted into bone, all of which are characteristic of a surgical implant, not a diagnostic tool. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly states it is a physical implantable suture anchor made of resorbable material, preloaded with sutures. It is a hardware 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a suture anchor) used to reattach soft tissue to bone during surgical procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The description focuses on the material, design, insertion method, and anatomical locations for its use in surgery. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Product codes
JDR, HWC
Device Description
The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The design enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Wrist/Hand, Elbow, 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: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Soft Tissue Screw and Washer (K012572)
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
K061657 page 14/
Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and black, with the exception of the letter "T", which has horizontal lines running through it. The overall design is geometric and modern.
JUL 25 2006
510(k) Summary
Arthrotek, Inc., Applicant/Sponsor: (A Wholly Owned Subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
May 25, 2006
Contact Person: Lester F. Padilla
Hitch™ LactoSorb® Suture Anchor Proprietary Name:
Common Name: Suture anchor
Classification Name: Fastener, fixation, biodegradable, soft tissue (21 CFR 888.3030)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Soft Tissue Screw and Washer (K012572) ●
Device Description:
Preparation Date:
The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The disign enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.
Intended Use:
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio:lavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, illotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Summary of Technologies: The Hitch™ LactoScrb® Suture Anchor has similar or identical technological characteristics (design, materials, and functional performance) as the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Arthrotek, Inc.
MAILING ADDRESS PO. Box 587 Warsaw, IN 46581 05837
트
SHIPPING ADDRESS 56 D. Bell Drive Warsaw, IN 46582
搜
( )['1'] '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' ' 5 / . ! . ! ( s / . ( s ( x ( x ( x ( x ( x ( x ( x ( x ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) (
5^1
574267-137
IC MAIL biomet@biomet.com
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2006
Arthrotek, Inc. % Biomet, Manufacturing Corp. Mr. Lester F. Padilla Regulatory Affairs Associate P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K061657
Trade/Device Name: Hitch™ LactoSorb® 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: JDR, HWC Dated: May 25, 2006 Received: June 13, 2006
Dear Mr. Padilla:
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
2
Page 2 – Mr. Lester F. Padilla
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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Barbara Buehrle
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indlications for Use
510(k) Number (if known): K061657
Device Name: Hitch™ LactoSorb® Suture Anchar
Indications for Use:
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment Indications for the meet - Eactober books, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
estorative.
510(k) Number K061657
Page 1 of 1