(85 days)
No
The device description and intended use clearly describe a physical implant (an interference screw) used in surgical procedures. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on mechanical testing, not algorithmic performance.
No
The device is described as an implant used for soft tissue reattachment and ligament reconstruction, functioning as an interference screw. It is a mechanical support device rather than one that treats or cures a disease or condition therapeutically.
No
The device, Bio-Core™ Interference Screw, is an implant used for fixation in soft tissue reattachment procedures. It is not involved in identifying or determining the nature of a disease or condition.
No
The device description clearly states it is an implantable screw made of LactoSorb, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable screw for soft tissue reattachment and ligament reconstruction procedures within the body (shoulder, wrist/hand, ankle/foot, elbow, and knee). This is a surgical device used in vivo.
- Device Description: The description details the physical characteristics of an implantable screw made of a resorbable material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Indications for the Bio-Core™ Interference Screw include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include, but are not limited to, the following:
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: 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, 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 cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis); and
- To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
Product codes
HWC
Device Description
The implant consists of a LactoSorb (85% PLLA/15% PGA) interference screw measuring in diameters from 7-12mm and in lengths from 20 to 30mm. The screw consists of a tapered tip and lattice body design. The internal drive of the screw is a cruciate shape that breaks through the minor diameter of the screw threads allowing an open lattice structure to be created. The internal drive area can be packed with autograft or allograft bone.
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
Mechanical testing was done on the Bio-Core Interference Screw. This testing indicated that the Bio-Core Interference Screw was substantially equivalent to the predicate devices.
Clinical testing was not required for these components to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Resorbable Interference Screw - Arthrotek, Inc. (K041274)
Reference Device(s)
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
DEC 1 4 2004
K0405-2 pge.f2
Image /page/0/Picture/2 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a bold, sans-serif font, with each letter enclosed in a square or circle. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font.
510(k) Summary
| Applicant/Sponsor: | Arthrotek, Inc. |
|---|---|
| Contact Person: | Susan Alexander |
| Regulatory Specialist | |
| Proprietary Name: | Bio-Core™ Interference Screw |
| Common Name: | Interference Screw |
| Classification Name: | Screw, Fixation, Bone (21 CFR §888.3040) |
| Legally Marketed Devices | |
| to Which Substantial | Equivalence Is Claimed: Resorbable Interference Screw - Arthrotek, Inc. (K041274) |
| Bone Mulch System - Biomet, Inc. (K993025, K991298, | |
| K941941) | |
| Device Description: | The implant consists of a LactoSorb (85% PLLA/15% PGA) |
| interference screw measuring in diameters from 7-12mm | |
| and in lengths from 20 to 30mm. The screw consists of a | |
| tapered tip and lattice body design. The internal drive of the | |
| screw is a cruciate shape that breaks through the minor | |
| diameter of the screw threads allowing an open lattice | |
| structure to be created. The internal drive area can be | |
| packed with autograft or allograft bone. | |
| Intended Use: | Indications for the Bio-Core™ Interference Screw include |
| use in soft tissue reattachment procedures in the shoulder, | |
| wrist/hand, ankle/foot, elbow, and knee. Specific indications | |
| include, but are not limited to, the following: | |
| 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: 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, 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: | |
| 1. To provide interference fixation of patellar bone- | |
| tendon-bone grafts in anterior cruciate ligament (ACL) | |
| reconstruction; | |
| 2. To provide interference fixation during femoral and/or | |
| tibial fixation in anterior cruciate ligament | |
| reconstruction using a soft tissue graft | |
| (semitendinosus, gracilis); and | |
| 3. To provide interference fixation during posterior | |
| cruciate ligament (PCL) reconstruction. | |
| Summary of | |
| Technologies: | The Bio-Core™ Interference Screw has the same intended |
| use and is made of a similar material and design as the | |
| resorbable predicate devices (K041274). | |
| Non-Clinical Testing: | Mechanical testing was done on the Bio-Core™ Interference |
| Screw. This testing indicated that the Bio-Core™ Interference | |
| Screw was substantially equivalent to the predicate devices. | |
| Clinical Testing: | Clinical testing was not required for these components to |
| support substantial equivalence. |
1
All trademarks are property of Biomet, Inc., with the exception of the following:
Bio-Core™ Interference Screw and Gentle Threads™ are trademarks of Arthrotek, Inc.
Tyvek® is
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Ms. Susan Alexander Regulatory Specialist Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K042552
Trade/Device Name: Bio-Core™ Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 17, 2004 Received: September 21, 2004
Dear Ms. Alexander:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro rove 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 for use stated in the encreations of 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). and Ocometier for ( 10) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . r ou may, aterer, mains 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. Susan Alexander
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" (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. Mellema
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: K042552
Device Name: Bio-Core™ Interference Screw
Indications For Use: Indications for the Bio-Core™ Interference Screw include 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-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament
reconstruction. stabilization, tendon Achilles medial Lateral stabilization, Ankle/Foot: repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar 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 higand 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 12.0 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 cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
-
- To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510 Number: K0432552
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