(171 days)
Not Found
No
The summary describes a mechanical fixation device (a cross pin) and its intended use in ACL reconstruction. There is no mention of software, algorithms, image processing, AI, ML, or any other technology that would suggest the incorporation of AI/ML. The performance studies focus on mechanical equivalence to a predicate device.
Yes
The device is used in ACL reconstruction procedures to provide suspension fixation, which directly treats an injury and restores function.
No
The device, a Biosteon cross pin, is used for suspension fixation during ACL reconstruction, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "cannulated Cross Pins" which are physical implants made of material (Biosteon®). This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed 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 provided information clearly describes a surgical implant (a cross pin) used to fix a soft tissue graft during ACL reconstruction surgery. This is a device used within the body for a structural purpose, not a test performed on a sample outside the body.
The device is a surgical implant used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
To hold a Semi Tendonosus ST or hamstring (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstructive surgery.
Surgical reconstruction of anterior cruciate ligament (ACL) deficient knee to provide cross pin femoral fixation of the various soft tissue ACL autografts and allografts.
The Biosteon® cross pin is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Biosteon® cross pin is used to provide suspension fixation during femoral fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The cannulated Cross Pins are 40-60mm long by 6-9mm diameter with a conical tip 10mm long.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral bone tunnel; femoral fixation in ACL reconstruction
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.
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
510(K) Summary
Submitter
Biocomposites Ltd Name: Address: Etruscan Street Etruria Stoke on Trent ST1 5PQ England +44 (0) 1782 206500 Tel No: Mr J. S. Bratt Contact: 25th April 2002 Date:
OCT 17 2002
Name of Device
Classification Name: Pin, Fixation, Smooth, Non-Metallic A device for holding soft tissue in apposition Common Name: Proprietary Name: Biosteon Cross Pin
Predicate Device
Arthrex Bio Transfix cross pin K011172 Biosteon Screw K003641
Device Function
To hold a soft tissue graft in position during healing in the femoral bone tunnel.
Device Design
The cannulated Cross Pins are 40-60mm long by 6-9mm diameter with a conical tip 10mm long.
Materials Used
The Cross Pin is moulded from a Poly L lactide/hydrox yapatite composite.
Intended Use
To hold a Semi Tendonosus ST or hamstring (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstructive surgery.
Substantial Equivalence
The material of construction and methods of manufacture, packaging and sterilization of the Biosteon Cross Pin are identical to the previously cleared Biosteon Screw K003641.
The function and indications for use of the Biosteon Cross Pin are the same as for the Arthrex Bio Transfix Cross Pin K011172.
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K021351 page 2 of 2
The functional mechanical performance characteristics of the Biosteon Cross Pin are equivalent to those of the Arthrex Bio Transfix Cross Pin. Any differences between the Biosteon Cross Pin and the predicate devices do not raise any new questions regarding safety and effectiveness.
Indications for use
Surgical reconstruction of anterior cruciate ligament (ACL) deficient knee to provide cross pin femoral fixation of the various soft tissue ACL autografts and allografts.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
CT 1 7 2002
Mr. J. Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Etruria, Stoke-on-Trent Staffordshire, ST1 5PQ, England
Re: K021351
Trade/Device Name: Biosteon® Cross Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 26, 2002 Received: July 29, 2002
Dear Mr. Bratt:
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 - Mr. J. Stephen Bratt
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). 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 N. Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Biosteon® Cross Pin
Indications For Use
The Biosteon® cross pin is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Biosteon® cross pin is used to provide suspension fixation during femoral fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
for Mark N. Milkman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO2135 510(k) Number _