(77 days)
Not Found
No
The 510(k) summary describes a resorbable interference screw used for soft tissue reattachment and ligament reconstruction. The description focuses on the material and mechanical properties of the screw and its substantial equivalence to predicate devices. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as an "Interference Screw" used in various soft tissue reattachment and ligament reconstruction procedures, which are therapeutic interventions.
No.
The device is a resorbable interference screw used for soft tissue reattachment and ligament reconstruction, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "Resorbable Interference Screw" made of "LactoSorb® material," which are physical components, not software. The intended use also describes surgical procedures involving the physical implantation of these screws.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the Resorbable Interference Screw clearly indicate it is a surgical implant used for reattaching soft tissue and providing fixation in various anatomical locations (shoulder, wrist/hand, ankle/foot, elbow, and knee). It is a physical device implanted into the body during a surgical procedure.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status.
Therefore, the Resorbable Interference Screw is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Resorbable Interference Screw is intended for soft tissue fixation to bone.
Indications For Use: Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/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, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:
-
- To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
-
- To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
-
- To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.
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, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices
Clinical Testing: Clinical testing was not required for these components to support 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
JUL 2 8 2004
K 041274
pg 1 of 2
510(k) Summary
Arthrotek. Inc. Applicant or Sponsor: (A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267-6639
FAX: (574) 372-1683 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Resorbable Interference Screw |
| Common or Usual Name: | Interference Screw |
Classification Name: Screw, Fixation, Bone (21 CFR §888.3040)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Arthrotek Interference Screw - Arthrotek Inc. (K982497) Soft Tissue Screw and Washer - Arthrotek Inc. (K012572) Resorbable Sorew Anchor - Arthrotek Inc. (K012872)
Device Description: The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.
Intended Use: The Resorbable Interference Screw is intended for soft tissue fixation to bone.
ਉਤੇ
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1999
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
FAX 574.267.8137
Image /page/0/Picture/17 description: The image contains a single Korean character, "그", which is written in black ink on a white background. The character is simple and bold. The image is minimalist and focuses solely on the single character.
Image /page/0/Picture/18 description: The image shows the text "E-Mail" in a stylized font, followed by the email address "blomet@biomet.com" on the line below. The email address is in a smaller, less stylized font. The text is likely part of a document or contact information.
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Page 2 of 2
Indications For Use: Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:
Shoulder: Batkart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/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, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:
-
- To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
-
- To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
-
- To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
Summary of Technologies: The Resorbable Interference Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Arthrotek Interference Screw (K982497). More sizes have been added.
Non-Clinical Testing: Mechanical testing was done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices
Clinical Testing: Clinical testing was not required for these components to support substantial equivalence
All trademarks are property of Blomel, Inc.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2004
Arthrotek, Inc. C/o Mr. Gary Baker Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K041274
Trade/Device Name: Resorbable Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 11, 2004 Received: May 12, 2004
Dear Mr. Baker:
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.
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Page 2 - Mr. Gary Baker
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) 594-4639. 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 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 A. Milken
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
Indications for Use
510(k) Number: K041274
Device Name: Resorbable Interference Screw
Indications For Use: Indications for the Resorbable Interference Screw includes use in soft tissue indications For OSC. Indications for the Resorbeative and knee. Specific indications include the following:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Capsure repair of odposition in reconstruction, ulnat/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
nanux valgus reconstruction, mar and collateral ligament reconstruction, biceps tendon reconstruction.
reconstruction.
Knee: Extra-capsular repair, media) collateral ligament (MCL) repair, lateral collected to desig (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis (CCC) repair, posterior oonque igazion repair, and vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mm screws are indicated for the following uses:
-
- To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
- To provide interference fixation during femoral and/or tibial fixation in anterior 2. To provide interestion using a soft tissue graft (semitendinosus, gracilis).
- To provide interference fixation during posterior cruciate ligament (PCL) 3. reconstruction.
Prescription Use (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)
Minh
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K041274
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