(85 days)
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.
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.
The provided document is a 510(k) summary for the Bio-Core™ Interference Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a specific study with defined performance metrics, as would be common for AI/ML-driven devices.
Therefore, many of the requested categories (acceptance criteria table, sample sizes for test/training, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to clinical or performance studies for novel device claims, which are not the primary focus of a 510(k) of this nature.
Here's an attempt to answer the questions based on the information available:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a reported device performance table in the way one would expect for an AI/ML device. For this traditional medical device, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through mechanical testing.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K041274, K993025, K991298, K941941) based on mechanical properties | "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." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document refers to "mechanical testing," which implies physical tests on a sample of devices, not a dataset of patient information. The number of devices tested is not specified.
- Data Provenance: Not applicable in the context of patient data. The "data" here would be the results of mechanical tests performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in this context would generally refer to a clinical diagnosis or outcome, which is not evaluated in this 510(k) submission. Mechanical testing results are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert assessments for ground truth establishment. Mechanical testing results are generally objective and do not require expert adjudication in this manner.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (an interference screw), not an AI-driven diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The relevant "truth" for this device's substantial equivalence claim is its mechanical performance as compared to predicate devices. This is established through direct measurements in a lab setting, not through expert consensus, pathology, or outcomes data in the usual sense for a 510(k) for a physical implant.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.
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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 AlexanderRegulatory Specialist |
| Proprietary Name: | Bio-Core™ Interference Screw |
| Common Name: | Interference Screw |
| Classification Name: | Screw, Fixation, Bone (21 CFR §888.3040) |
| Legally Marketed Devicesto 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 7-12mmand in lengths from 20 to 30mm. The screw consists of atapered tip and lattice body design. The internal drive of thescrew is a cruciate shape that breaks through the minordiameter of the screw threads allowing an open latticestructure to be created. The internal drive area can bepacked with autograft or allograft bone. |
| Intended Use: | Indications for the Bio-Core™ Interference Screw includeuse in soft tissue reattachment procedures in the shoulder,wrist/hand, ankle/foot, elbow, and knee. Specific indicationsinclude, 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, deltoidrepair.Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. | |
| Ankle/Foot: Lateral stabilization, medial stabilization, Achillestendon repair/reconstruction, hallux valgus reconstruction,mid- and forefoot reconstruction. | |
| Elbow: Tennis elbow repair, ulnar or radial collateralligament 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, patellarligament/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 followinguses: | |
| 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/ortibial fixation in anterior cruciate ligamentreconstruction using a soft tissue graft(semitendinosus, gracilis); and | |
| 3. To provide interference fixation during posteriorcruciate ligament (PCL) reconstruction. | |
| Summary ofTechnologies: | The Bio-Core™ Interference Screw has the same intendeduse and is made of a similar material and design as theresorbable predicate devices (K041274). |
| Non-Clinical Testing: | Mechanical testing was done on the Bio-Core™ InterferenceScrew. This testing indicated that the Bio-Core™ InterferenceScrew was substantially equivalent to the predicate devices. |
| Clinical Testing: | Clinical testing was not required for these components tosupport substantial equivalence. |
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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
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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.
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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
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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
Page 1 of 1
§ 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.