(71 days)
Not Found
Not Found
No
The device description focuses on physical implants (plates and screws) and their dimensions, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is a surgical implant used to stabilize fractures and dislocations in the pelvic region, rather than providing therapy in the traditional sense (e.g., drug delivery, physical therapy, or diagnostic imaging).
No
The device, the Stryker Trauma Pelvic Set, is described as consisting of reconstruction plates, acetabulum plates, and symphysis-pubis plates used for treating fractures and other conditions of the pelvic region. Its function is to provide structural support for treatment, not to diagnose a condition.
No
The device description clearly states that the device consists of physical components such as plates and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Description and Intended Use: The Stryker Trauma Pelvic Set is a collection of plates and screws designed to be surgically implanted to stabilize and repair fractures and other injuries to the pelvic region. It is a surgical implant, not a device that analyzes biological samples.
The information provided clearly describes a surgical implant used for structural support within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Trauma Pelvic Set is indicated for:
- Fractures of the acetabulum, sacrum, illium, and entire pelvic ring .
- Revision surgery of pseoduarthroses, non-unions and mal-unions .
- Osteonomies ●
- Arthrodeses ●
- . Sacroilic joint dislocations
- Symphysis pubis disruptures ●
Product codes (comma separated list FDA assigned to the subject device)
KTW
Device Description
The Stryker Trauma Pelvic Set consists of various plates, buttress plates, reconstruction plates, and symphysis-pubis plates. All curved and straight plates are available in 2.0mm and 2.5mm thicknesses. The symphysis-pubis plates are also available in a 1.2mm thickness. The subject components vary in length from 60mm to 12 holes. The system includes 3.5mm diameter and 4.5mm diameter screws. All devices in the system are provided both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic ring, acetabulum, sacrum, illium, Sacroilic joint, Symphysis pubis
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.
The Stryker Trauma Pelvic Set is substantially equivalent to the Synthes Pelvic Implant Set.
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
4 2000 AUG
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Stryker Trauma Pelvic Set
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Regulatory Affairs Team Member
Mary-Catherine Dillon
March 23, 2000
Contact Person:
Date Summary Prepared:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Stryker Trauma Pelvic Set
Pelvic Set
Plate, Fixation, Bone 21 CFR §888.3030
Predicate Device Identification
The Stryker Trauma Pelvic Set is substantially equivalent to the Synthes Pelvic Implant Set.
Device Description
Device Description I he buyker Trainia Perrobulum plates, and symphysis-pubis plates. All curves and straight plate pervice plates, buttight accuse pravidens and 2.5mm thicknesses. The symphysis-pubis plates are components arouventions in rotening 1.2mm thickness. The subject components vary in length from also available in a 12.5mm Water and shincludes 3.5mm diameter and 4.5mm diameter screws. All devices in the system are provided both sterile and non-sterile.
Intended Use
The Stryker Trauma Pelvic Set is indicated for:
- Fractures of the acetabulum, sacrum, illium, and entire pelvic ring .
- Revision surgery of pseoduarthroses, non-unions and mal-unions .
Kooib14
1
- Osteonomies ●
- Arthrodeses ●
- . Sacroilic joint dislocations
- Symphysis pubis disruptures ●
Materials
The subject components are manufactured from stainless steel which conforms to ASTM F-138.
Statement of Technological Comparison
The subject components of the Stryker Trauma Pelvic Set are substantially equivalent in design and intended use to the predicate device offered by Synthes.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Ms. Mary-Catherine Dillon Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K001614
Trade Name: Stryker Trauma Pelvic Set Regulatory Class: II Product Code: KTW Dated: May 24, 2000 Received: May 25, 2000
Dear Ms. Dillon:
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 Flectronic 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 parketed predicate device results in a classification for your device and thus, permits your dryice to proceed to the market.
3
Page 2 - Ms. Mary-Catherine Dillon
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. 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 obtained from the Division of Small Manufacturers Assistance at its 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,
Duma 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
4
510(k) Number (if known): KOO ﺎ ﻫﺎﻟﻢ ﺍ ﻫﺎﻟﻜ
Device Name: Stryker Trauma Pelvic Set
Indications For Use:
The Stryker Trauma Pelvic Set is indicated for:
- Fractures of the acetabulum, sacrum, illium, and entire pelvic ring
- Revision surgery of pseoduarthroses, non-unions and mal-unions
- Osteonomies
- . Arthrodeses
- Sacroilic joint dislocations
- Symphysis pubis disruptures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. Vochner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number KOO 1614
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)