(30 days)
Not Found
Not Found
No
The document describes a mechanical device (plates and screws) for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance study is a mechanical FEA analysis.
Yes
The device is described as plates and screws used for the fixation of long bone fractures, which directly treats an injury.
No
This device is a surgical implant (plate and screws) used for fracture fixation, which is a treatment, not a diagnostic process.
No
The device description explicitly states it consists of "plates and screws" made of "stainless steel (316L)", which are physical hardware components for fracture fixation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "long bone fracture fixation." This is a surgical procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as "plates and screws for the fixation of fractures." These are implants used to stabilize bones, not reagents or instruments for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is clearly a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Periarticular Plates are intended for use in long bone fracture fixation.
The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.
The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.
Product codes (comma separated list FDA assigned to the subject device)
87 HRS, 87 HWC, LXT
Device Description
This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, tibia, femur.
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)
FEA analysis demonstrates the comparable mechanical properties of the subject Periarticular Plates and predicate SPS Basic Fragment Set.
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
§ 888.3030 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
Line Extension to the SPS Small Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates
Special 510(k) Premarket Notification
JUL 2 5 2003
Special 510(k) Summary of Safety and Effectiveness: Line Extension t Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates
Submission Information
| | Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp.
59 Route 17 South
Allendale, NJ 07401-1677 |
|--|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Vivian Kelly
Regulatory Affairs Consultant
Phone: 201-831-5581
Fax: 201-831-6038 |
| | Date of Summary Preparation: | June 18, 2003 |
| | Device Identification | |
| | Proprietary Name: | Stryker Plating System Periarticular Plates |
| | Common Name: | Bone Plate System |
| | Classification Name and Reference: | Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories, 21 CFR §888.3030
Smooth or Threaded Metallic Bone Fixation
Fastener, 21 CFR §888.3040 |
Regulatory Class:
Description
This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).
Class II
Intended Use
The Periarticular Plates are intended for use in long bone fracture fixation.
Substantial Equivalence
Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed plating systems. Analysis has been conducted demonstrating substantial equivalence to a currently marketed device.
Statement of Technological Comparison
FEA analysis demonstrates the comparable mechanical properties of the subject Periarticular Plates and predicate SPS Basic Fragment Set.
1
Line Extension to the SPS Small Fragment Set and SPS Basic Fragment Set - 3.5mm and 4.5mm Periarticular Plates
Special 510(k) Premarket Notification
Device Identification
KO31959
page 2 of 2
Proprietary Name:
Stryker Plating System Periarticular Plates
Common Name:
Bone Plate System
Class II
Classification Name and Reference:
Single/Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR §888.3030
Smooth or Threaded Metallic Bone Fixation Fastener, 21 CFR §888.3040
Proposed Regulatory Class:
Device Panel/Product Code:
87 HRS: Plate, Fixation, Bone 87 HWC: Screw, Fixation, Bone
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
JUL 25 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K031959
Trade/Device Name: Stryker Plating System Periarticular Plates Regulation Number: 21 CFR 3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 18, 2003 Received: June 25, 2003
Dear Ms. Kelly:
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
3
Page 2 - Ms. Vivian Kelly
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 (301) 594-4659. 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 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.
to Mark A. Milkerson
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
Page 1 of 1
510(k) Number (if known): K031959
Device Name: 3.5mm and 4.5mm Periarticular Plates
Indications For Use:
The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.
The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
Ad. Mem.
vision of General. Restorative and Neurological Devices
510(k) Number _