(67 days)
No
The document describes a resorbable fixation system made of plates and screws for craniofacial and midfacial bone fixation. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
A therapeutic device is one that treats a disease or condition. This device is for fixation of bones, which is a supportive rather than a therapeutic function.
No
The device is described as a fixation system (plates, screws, mesh) used to fix broken bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (plates, screws, mesh) made from a specific material, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details plates, screws, and mesh made from a polymer, designed for physical fixation of bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
Product codes
MAI, HWC, HRS
Device Description
The Stryker Leibinger Resorbable Fixation System is a modification of the Howmedica Leibinger Resorbable Fixation System, K982531. This second generation of products includes plates and screws in various configurations. Plates include but are not limited to straight, curved, "X", "Y", zigzag, "L", box, ladder, and panel designs in varying lengths which are attached to the bone using screw fixation. The plates have a thickness of 1.0mm. The system also contains a mesh which is available in a thickness of 0.7mm. Screws are available in 1.7 mm, 2.0 mm and 2.2 mm diameters and standard craniofacial lengths. The plates and mesh can be intraoperatively contoured by heating. The subject device is fabricated from a polylactide and polyglycolide terpolymer. Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial and midfacial skeleton
Indicated Patient Age Range
adult and pediatric patients
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
Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device.
Key Metrics
Not Found
Predicate Device(s)
K982531, K971870, K972913, K982139
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Nov 1 9 1999
510(k) Summary of Safety and Effectiveness: Stryker Leibinger Resorbable Fixation System
General Information
| Proprietary Name: | Stryker Leibinger Resorbable Fixation System |
|---|---|
| Common Name: | Small Bone Plating System |
| Classification Name: | Single/Multiple Component Metallic Bone |
| Fixation Appliances and Accessories | |
| Classification Code: | 87HRS |
| Submitter: | Stryker Leibinger |
| 4100 E. Milham Ave. | |
| Kalamazoo, MI 49001 | |
| Submitter's Registration | |
| Number: | 1811755 |
| Manufacturer's Registration | |
| Number: | 1811755 |
| Contact Person: | Kristyn R. Kelley |
| Project Engineer | |
| Quality Assurance and Regulatory Affairs | |
| 616-323-7700 x3814 | |
| Summary Preparation Date: | September 7, 1999 |
Equivalent Devices
The Stryker Leibinger Resorbable Fixation System is equivalent to the Howmedica Leibinger Resorbable Fixation System, Howmedica, K982531; the LactoSorb Trauma Plating System, Walter Lorenz, subsidiary of Biomet, K971870; the Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces, K972913; and the BiosorbFX 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc., K982139.
Device Description
The Stryker Leibinger Resorbable Fixation System is a modification of the Howmedica Leibinger Resorbable Fixation System, K982531. This second generation of products includes plates and screws in various configurations. Plates include but are not limited to straight, curved, "X", "Y", zigzag, "L", box,
1
ladder, and panel designs in varying lengths which are attached to the bone using screw fixation. The plates have a thickness of 1.0mm. The system also contains a mesh which is available in a thickness of 0.7mm. Screws are available in 1.7 mm, 2.0 mm and 2.2 mm diameters and standard craniofacial lengths. The plates and mesh can be intraoperatively contoured by heating. The subject device is fabricated from a polylactide and polyglycolide terpolymer. Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device.
Intended Use
The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
Substantial Equivalence
The subject device is substantially equivalent to the above mentioned devices in material, design, operational principle and intended use.
2
Image /page/2/Picture/2 description: The image shows a partial view of a circular emblem or logo. The text "DEPARTMENT OF HEALTH & HUM" is visible along the curved edge of the circle, suggesting it is part of a larger phrase. To the right of the text, there is a stylized graphic consisting of three curved lines that appear to be interconnected or layered. The overall design is simple and uses a bold, black-and-white color scheme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 19 1999
Ms. Kristyn R. Kelley Project Engineer Quality Assurance and Regulatory Affairs Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K993061 Stryker Leibinger Resorbable Fixation System Regulatory Class: II Product Codes: MAI, HWC, and HRS Dated: September 7, 1999 September 13, 1999 Received:
Dear Ms. Kelley:
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 controls provisions The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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.
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Page 2 - Ms. Kristyn R. Kelley
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your blown) privalence of your device to a legally rinding of cabboanderice results in a classification for your marketed produce awits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of vitto draghosere actross// productionally, 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be information on your with of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stryker Leibinger Resorbable Fixation System
Indications For Use:
The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
(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 Devices | |
| 510(k) Number | K993061 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The- Counter Use |
| (Optional Format 1-2-96) |