(317 days)
Not Found
No
The device description and intended use are for a physical implant (interference screw) used in ACL reconstruction. There is no mention of software, data analysis, or any technology that would typically incorporate AI/ML.
No.
The device is described as an interference screw system used in surgical reconstruction for fixation of grafts, which is a supportive role in surgery, not a direct therapeutic action to treat a disease or condition itself.
No
The device is described as an "Interference Screw System" intended for surgical reconstruction and fixation of ACL grafts, rather than for diagnosing a medical condition.
No
The device description explicitly states it is a "Stryker Bioabsorbable Interference Screw System," which is a physical implantable device used in surgical procedures, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a device used for the surgical reconstruction of the anterior cruciate ligament (ACL) in the knee. It is a physical implant (a screw system) used to fix grafts during surgery.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples from the patient. The device is used directly within the body during a surgical procedure.
Therefore, based on the provided information, the Stryker Bioabsorbable Interference Screw System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Bioabsorbable Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
Product codes (comma separated list FDA assigned to the subject device)
87 HWC, MAI
Device Description
The Stryker Bioabsorbable Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550) and validated to a sterility assurance level (SAL) of 10. The device is biocompatible per ISO-10993 and G95-1.
Poly(L-lactic Acid), Sterile Single-use, Ethylene Oxide or Gamma Radiation, 24 months.
Diameter: 6mm-11mm, Length: 20mm-35mm, Tapered Wedge, Cannulated, Rounded Head, non-symmetric, buttress-shaped thread, spiral thread.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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
AUG 4 2000
Image /page/0/Picture/2 description: The image shows the logo for Stryker Endoscopy. The word "Stryker" is in a bold, sans-serif font, with the letters slightly overlapping. Above the "r" in Stryker is a registered trademark symbol. Below Stryker is the word "ENDOSCOPY" in a smaller, sans-serif font.
2590 Walsh Avenue. Santa
(408) 567-9100
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name:
| Classification Name: | Screw, Fixation, Bone, under 21 CFR, 888.3040 |
|---|---|
| Device Product Code: | 87 HWC and MAI |
| Common and Usual Name: | Interference Screw |
| Proprietary Name: | Stryker Bioabsorbable Interference Screw System |
Regulatory Classification: Class II
Safety and Effectiveness Summary:
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Stryker Bioabsorbable Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The Stryker Bioabsorbable Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550) and validated to a sterility assurance level (SAL) of 10 . The device is biocompatible per ISO-10993 and G95-1. The Stryker Bioabsorbable Interference Screw System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution. The material of construction and its overall design are equivalent to currently marketed products.
The Stryker Bioabsorbable Screw is substantially equivalent to the Linvatec BioScrew (510(k) K973758 ) in the following fields:
- · Intended use
- · Material
- · Thread design
- · Head design
- · Shelf life
1
The Stryker Bioabsorbable Screw is substantially equivalent to the Stryker Wedge Interference Screw (510(k) K972233 ) in the following fields:
- · Intended use
- · Geometry
- · Thread design
- · Head design
Specific similarities/dissimilarities to the predicates are shown in Table 1 and Table 2.
Table 1: Comparison of Stryker Bioabsorbable Interference Screw to Linvatec BioScrew and Stryker Wedge Screw
| Name | Device Name | Indication for Use | Material | Sterility | Method of Sterilization | Shelf Life |
|---|---|---|---|---|---|---|
| New | ||||||
| Product | Bioabsorbable | |||||
| Interference Screw | Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. | Poly(L-lactic | ||||
| Acid) | Sterile | |||||
| Single-use | Ethylene Oxide | |||||
| or | ||||||
| Gamma | ||||||
| Radiation | ||||||
| (pending post-prototype | ||||||
| sterilization | ||||||
| testing) | 24 months | |||||
| Predicate | BioScrew | |||||
| Absorbable | ||||||
| Interference Screw | ||||||
| (K973758) | Provide interference fixation: | |||||
| Patellar bone-tendon-bone grafts in ACL reconstruction | ||||||
| Femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft. | ||||||
| PCL reconstruction | Poly(L-lactic | |||||
| Acid) | Sterile | |||||
| Single-use | Ethylene Oxide | 24 months | ||||
| Predicate | Wedge Interference | |||||
| Screw | ||||||
| (K972233) | Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft | Titanium | ||||
| (Ti 6Al 4V) | Sterile | |||||
| Single-use | Ethylene Oxide | |||||
| and | ||||||
| Gamma | ||||||
| Radiation | 5 years | |||||
| Stryker | ||||||
| Linvatec | ||||||
| Stryker |
2
| New
Product
Stryker | Bioabsorbable
Interference
Screw | Diameter:
6mm-11mm
Length:
20mm-35mm | Tapered Wedge | Cannulated | Rounded Head | non-
symmetric,
buttress-
shaped thread | spiral
thread |
|---------------------------|--------------------------------------------------------------|-----------------------------------------------|---------------|---------------------------|-------------------------------------|--------------------------------------------------|------------------|
| Predicate
Linvatec | BioScrew
Absorbable
Interference
Screw
(K973758) | Diameter:
7mm-11mm
Length:
20mm-30mm | Cylindrical | Cannulated | Rounded Head
&
Fully Threaded | non-
symmetric,
buttress-
shaped thread | spiral
thread |
| Predicate
Stryker | Wedge
Interference
Screw
(K972233) | Diameter:
7mm-10mm
Length:
20mm-35mm | Tapered Wedge | Cannulated
or
Solid | Rounded Head | non-
symmetric,
buttress-
shaped thread | spiral
thread |
Table 2: Comparison of Stryker Bioabsorbable Interference Screw to Linvatec BioScrew and Stryker Wedge Screw
The screw system does not raise any new safety and efficacy concerns when compared to other devices currently on the market. Therefore, the Stryker Bioabsorbable Interference Screw System is substantially equivalent to other ACL fixation devices.
Jodd Miller
Todd Miller, M.S.E. Design Engineer
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 2000
Mr. Todd Miller Stryker Endoscopy In corporated 2590 Walsh Avenue Santa Clara, California 95051
Re: K993166 Trade Name: Stryker Bioabsorbable Interference Screw Regulatory Class: II Product Code: HWC, MAI Dated: May 1, 2000 Received: May 11, 2000
Dear Mr. Miller:
This letter corrects the Indications For Use Enclosure included within our substantially equivalent letter of August 4, 2000 which incorrectly referenced your device as the "Stryker Wedge Suture Anchor System." This letter includes a corrected Indication for Use Form that correctly refers to your device as the "Stryker Bioabsorbable Interference Screw."
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Fedcral Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under scctions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Todd Miller
This letter will allow you to continue marketing your device as described in your 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
e P. Vochner.
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
5
Page
510(k) Number (if known): __ ڪ 9 9 31 (6 6)
Device Name: Stryker Bioabsorbable Interference Screw
Indications For Use:
Intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NFEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Demme R. Lochner.
(Division Sign-Off)
Division of General Restor... Devices
510(k) Number K993166
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Mr. Todd Miller Stryker Endoscopy Incorporated 2590 Walsh Avenue Santa Clara, California 95051
Re: K993166 Trade Name: Stryker Bioabsorbable Interference Screw Regulatory Class: II Product Code: HWC, MAI Dated: May 1, 2000 Received: May 11, 2000
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
7
Page 2 - Mr. Todd Miller
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice in your devices), please contact the Office of Compliance at
additionally 809.10 for in vitto diagnostic devices), please contact the Office of additionally 809.10 for in the daguestic on the promotion and advertising of your device, (301) 594-4659. Additionally, for questions on the promons in iso, please note the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please note t please contact the Office of Compilance at (301) - 1037 - 1037 - 1037 - 1031 - 101.97). Other general
entitled, "Misbranding by reference to premarks obteined from the Divis entitled, "Misbranding by reference io premation of size drom the Division of Small
information on your responsibilities under the Act may be obtains of Small information on your responsionines under (800) 638-2041 or at (301) 443-6597, or at its
Manufacturers Assistance at its toll-free 111 Manufacturers Fribibianssww.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Danne R. Lochner
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