(460 days)
No
The device description and intended use focus solely on a physical, bio-absorbable screw for surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device, a PLLA cannulated interference screw, is used for fixation of grafts during ACL repair, which is a supportive role in a surgical procedure, not a direct therapeutic action on a disease or condition itself.
No
The device description indicates it is a bio-absorbable screw used for fixation during ACL repair, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical, bio-absorbable screw made of PLLA, which is a hardware component used for surgical fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide interference fixation of soft tissue and bone grafts during ACL repair. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical screw designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used to physically stabilize a repair.
N/A
Intended Use / Indications for Use
The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures.
To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.
Product codes
HWC
Device Description
The PLLA cannulated interference screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue grafts and bone-tendonbone patellar grafts during Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.
The screw comes in multiple lengths (20mm to 45mm), multiple diameters (6mm to 12mm) in each length and left and right thread design, resulting in a set of screws adapted to the morphology of the graft and the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior Cruciate Ligament
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY FOR THE PLLA CANNULATED INTERFERENCE SCREW
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510k #: K032438
DEC 1 4 2004
ADVANCED BIOMATERIALS Company: 265 Route de La Baronne, St. Jeannet 06640 France Adresse: Phone: +33-4-92-12-04-74 +33-4-92-12-48-70 Fax:
Mr Patrick Janin Contact:
September 10th 2003 Date of submission:
Name of device:
PLLA cannulated interference screw
Common or usual name:
Bioabsorbable interference screw
Classification:
Smooth or threaded bone fixation fastener: 888.3040
Predicate device:
FMS Cannulated bioabsorbable interference screw (K013685) Arthrex Bio-interference screw (K971358)
Device description:
The PLLA cannulated interference screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue grafts and bone-tendonbone patellar grafts during Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.
Intended use:
The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures.
The ABS interference screw and predicate device have overall same intended use and design despite some minor modifications which does not affect the reconstruction process.
Both implants are made of similar biopolymer (polylactic acid)
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510(k) SUMMARY FOR THE PLLA CANNULATED INTERFERENCE SCREW
The screw comes in multiple lengths (20mm to 45mm), multiple diameters (6mm to 12mm) in each length and left and right thread design, resulting in a set of screws adapted to the morphology of the graft and the patient.
Substantial equivalence:
The polymer for the ABS interference screw has similar characteristics than the polymer use for the predicate device (both are poly L.D lactic acid) and is currently use in many devices which have received FDA marketing clearance, and has undergone many in vitro and in vivo testing.
The PLLA cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device.
The principal difference in the insertion technique between the ABS PLLA screw and the Arthrex bio-interference screw is the method of attaching the screwdriver to the screw during insertion.
The ABS interference screw is equivalent in material, design and intended use as the predicate device.
Based on these similarities and equivalences we believe our PLLA cannulated interference screw and the Arthrex bio-interference screw K971538 are substantially equivalent for the interference fixation of soft tissue and Bone Tendon Bone graft in the ACL reconstruction through arthroscopy or arthrotomy.
Indications for use:
To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Mr. Patrick Janin President Advanced Biomaterials 265 Route de la Baronne F-06640 St. Jeannet France
Re: K032830
Trade/Device Name: PLLA cannulated interference screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: October 19, 2004 Received: October 21, 2004
Dear Mr. Janin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your se determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreativent of the enactment date of the Medical Device Amendments, or to connered prof to they 2011-12-12 accordance with the provisions of the Federal Food, Drug, de nees that have been 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. Patrick Janin
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 Walker
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 (if known): Ko Z > { } &
Device name: PLLA cannulated interference screw
Indications For Use:
To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.
Prescription Use y 22 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
e-Counter Use
(21 CFR 807 Subpart C) No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Milliken
Division Sign-Off
Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K032850