(233 days)
No
The summary describes a physical implant (screw) and its material composition and design modifications. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for interference fixation of grafts in ligament reconstructions, which is a therapeutic intervention aimed at restoring function and treating an injury.
No
Explanation: The Osteo ACL Screw™ is an implantable device used for interference fixation of grafts in ligament reconstructions. Its purpose is therapeutic (fixation of grafts), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states the device is an implant composed of a mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate, indicating it is a physical medical device, not software.
Based on the provided text, the Osteo ACL Screw™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions." This describes a surgical implant used in vivo (within the body) to physically secure tissues.
- Device Description: The description details the material composition (poly-lactide copolymer and tri-calsium phosphate) and physical characteristics (lengths, diameters, thread profile) of a solid implant.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Osteo ACL Screw™ is an in vivo surgical implant.
N/A
Intended Use / Indications for Use
The Osteo ACL Screw™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The Osteo ACL Screw™ is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active separas or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The device description of the Osteo ACL Screw is as follows,
- The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate devices like Mitek Biocryl Interference Screws (013572) and Biocomposites Ltd Biolok (K993630, K002070) are utilizing mixture of poly-L-lactide and tri-calsium phosphate.
- Lengths of implant are 20 30 mm -
- -Diameters of implant are 7mm-11mm.
The only modifications that were made are:
- Amendment of a new raw material option, mixture of poly-961/4D-lactide copolymer and tricalsiumphosphate (TCP).
- Design of driver hole is adapted of Linvatec BioScrew implant (K933719, -K952831, K973758).
- Thread profile is adjusted to fit with bone taps of Linvatec BioScrew implant -(K933719, K952831, K973758).
- Reference numbers for these new screw versions. These changes are updated in labelling.
- New trade name to separate it from SmartScrew ACL. This change is updated in labelling.
- Revision of insert sheet concerning adaption of instrumentation of BioScrew. -
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
K993073, K012572, K933719, K952831, K973758, K993630, K002070
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
K012894 pge.1 of 2
MAY - 7 2004
510(k) Summary Linvatec Biomaterials Osteo ACL Screw
Submitter's Name, Address, Telephone Number, and Contact Person
Linvatec Biomaterials Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe Phone: 358-3-316 5600 Facsimile: 358-3-316 5629
Bioabsorbable Interference Screw
Bone Fixation Screw
MAI and HWC
Date prepared: August 21, 2003
Name of the device:
- A. Trade or Proprietary Name: Osteo ACL Screw
- B. Common Name:
- C. Classification Name:
Device Product Code: D.
Predicate Device:
-
- Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) K993073
-
- Mitek Products Mitek Biocryl Interference Screws (K012572)
Intended Use:
The Osteo ACL Screw™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The Osteo ACL Screw™ is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active separas or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.
1
Page 2 of 2
Device Description:
The device description of the Osteo ACL Screw is as follows,
- The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate devices like Mitek Biocryl Interference Screws (013572) and Biocomposites Ltd Biolok (K993630, K002070) are utilizing mixture of poly-L-lactide and tri-calsium phosphate.
- Lengths of implant are 20 30 mm -
- -Diameters of implant are 7mm-11mm.
The only modifications that were made are:
- Amendment of a new raw material option, mixture of poly-961/4D-lactide copolymer and tricalsiumphosphate (TCP).
- Design of driver hole is adapted of Linvatec BioScrew implant (K933719, -K952831, K973758).
- Thread profile is adjusted to fit with bone taps of Linvatec BioScrew implant -(K933719, K952831, K973758).
- Reference numbers for these new screw versions. These changes are updated in labelling.
- New trade name to separate it from SmartScrew ACL. This change is updated in labelling.
- Revision of insert sheet concerning adaption of instrumentation of BioScrew. -
Substantial Equivalence:
Linvatec Biomaterials Ltd (the previous Bionx Implants Inc.) Osteo ACL Screw is stantially equivalent to the cleared predicate devices. The applied modifications do not raise any new concerns of safety and efficacy of the implant.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. P.O. Box 3 Hermiankatu 6-8 L FIN 33721 Tampere, Finland
Re: K032894
Trade/Device Name: Osteo ACL Screw™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 18, 2004 Received: February 23, 2004
Dear Ms. Annala:
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.
3
Page 2 - Ms. Tuija Annala
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 vours.
Sincerely, yours,
L. Mark A. Melkerson
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 (if known): K012894
Device Name:
Osteo ACL Screw
Indications for Use:
The Osteo ACL Screw™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The Osteo ACL Screw™ is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.
(Flease do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(F'er 21 CFR 801.109)/
OR Over-The-Counter Use
Mark n Miller
(Division Sign-Off)
Division of General Postonoting
I, Restorative. and Neurological Devices
510(k) Number K032894