(29 days)
Not Found
Not Found
No
The document describes a mechanical bone screw for ACL reconstruction and makes no mention of AI or ML technology.
Yes
The device is used to fix grafts during ACL reconstruction procedures, which is a therapeutic intervention to treat a medical condition (ACL tear).
No
The device is described as a screw used for fixation during ACL reconstruction procedures. Its function is to hold a graft in place, which is a therapeutic or reconstructive action, not a diagnostic one.
No
The device description explicitly states that the GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screws manufactured from poly L-lactic acid (PLLA), which are physical hardware components.
Based on the provided information, the GraftLok™ Screw and GraftLok™ ST Screw are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure (ACL reconstruction) where the screws are used to physically fix a graft within bone tunnels. This is a mechanical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a bone screw made of PLLA, designed for physical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GraftLok™ screws do not fit this description.
N/A
Intended Use / Indications for Use
The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLok™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. GraftLok™ ST Screw is used to provide suspensary fixation femoral fixation during double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDR, MAI
Device Description
The GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screw manufactured from poly L-lactic acid (PLLA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial and/or femoral tunnels (for ACL reconstruction)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Non Clinical Testing
Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent to the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent to the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
Safety and Performance
Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent to the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
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.
Not Found
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
K07195(-2
510(k) SUMMARY
GraftLok™ Screw GraftLok™ ST Screw
AUG 1 4 2007
| Applicant | Biocomposites Ltd |
|---|---|
| Keele Science Park | |
| Keele | |
| Staffordshire | |
| England | |
| ST5 5NL |
- Contact Person Mr Simon Fitzer +44 (0) 1782 338580 Tel: +44 (0) 1782 338599 Fax Email: sf(@biocomposites.com
| Classification Name: | Screw, fixation, bone |
|---|---|
| Common/Usual Name: | Bone screw |
| Trade/Proprietary Name | GraftLok™ Screw |
| GraftLok™ ST Screw | |
| Product Code | HWC |
| CFR Section | 21CFR888.3040 |
Device Description
The GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screw manufactured from poly L-lactic acid (PLLA).
Intended Use / Indications
The GraftLok™ Screw and the GraftLok™ ST Screw have the exact same intended use and indications as the predicate devices.
The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLok™ Screw is used to provide interference fixation of patellar bone-tendon-
bone grafts in ACL reconstruction.
The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
1
The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. GraftLok™ ST Screw is used to provide suspensary fixation femoral fixation during double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Summary of Technology
The GraftLok™ Screw and GraftLok™ ST Screw have the same technological characteristics as the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
Non Clinical Testing
Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent to the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent to the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
Safety and Performance
Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent to the legally marketed predicate devices and any differences do not raise any concerns regarding safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biocomposites Ltd % Mr. Simon Fitzer Keele Science Park Keele Staffordshire England STS SMT
AUG 1 4 2007
Re: K071952
Trade/Device Name: GraftLok™ Screw and GraftLok™ ST Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: July 9, 2007 Received: July 16, 2007
Dear Mr. Fitzer:
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. Ilisting 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
3
Page 2 - Mr. Simon Fitzer
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely Nour
Fon Vek
Mark N. Melkerson 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
071952
510(k) Number (if known):
Device Name:
GraftLok™ Screw
Indications For Use:
The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.
The GraftLok™ Screw is used to provide interference fixation of patellar bonetendon-bone grafts in ACL reconstruction.
The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi tendonosis gracilis).
| Prescription Use | OR | Over-The-Counter use | No | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 807 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 2071982 |
|---|---|
| --------------- | --------- |
51 Page 1 of 2
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
GraftLok™ ST Screw
Indications For Use:
The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The GraftLok™ ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Prescription Use OR (Part 21 CFR 801 Subpart D)
Over-The-Counter use NO (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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