(51 days)
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No
The device description and intended use are solely focused on mechanical implants (plates and screws) for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device, a Basic Fragment Set, is intended for long bone fracture fixation, which is a therapeutic intervention.
No
The device description clearly states it is a set of plates and screws for fixation of fractures, which are used in treatment, not diagnosis. The "Intended Use" section also outlines its use in "fracture fixation" for various bone fractures.
No
The device description explicitly states that the Basic Fragment Set consists of plates and screws, which are physical hardware components used for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for use in long bone fracture fixation." This describes a surgical implant used directly on the patient's body to stabilize fractures.
- Device Description: The description details plates and screws made of stainless steel or titanium alloy, which are materials used for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. IVDs are used for diagnosis, monitoring, or screening, not for direct surgical intervention.
This device is a surgical implant, specifically a bone fixation system.
N/A
Intended Use / Indications for Use
The Basic Fragment Set is intended for use in long bone fracture fixation.
Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:
- Fractures of the femur.
- Fractures of the tibia.
- Fractures of the humerus.
- Fractures of the pelvis.
T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:
- Fractures of the femoral condyles.
- Fractures of the tibial plateau.
- Fractures of the distal tibia.
- Fractures of the proximal-humerus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set is consists of plates and screws for the fixation of fractures of the cortical and metaphyseal area of long bones as well as fractures of the pelvis. The implant set is available either in stainless steel (316L) or titanium alloy (Ti6Al4V).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Long bones, femur, tibia, humerus, pelvis, femoral condyles, tibial plateau, distal tibia, proximal-humerus.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Basic Fragment Set
AUG 3 1 2001
510(k) Summary of Safety and Effectiveness for the Basic Fragment Set
| Proprietary Name: | Stryker Plating System Basic Fragment Set |
|---|---|
| Common Name: | Bone Plate System |
| Classification Name and Reference | 21 CFR §888.3030 and 21 CFR §888.3040 |
| Regulatory Class: | Class II |
| For Information contact: | Karen Ariemma, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| Phone: (201) 760-8187 | |
| Fax: (201) 760-8435 | |
| Date Summary Prepared: | July 10, 2001 |
Intended Use:
The Basic Fragment Set is intended for use in long bone fracture fixation.
Description:
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set is consists of plates and screws for the fixation of fractures of the cortical and metaphyseal area of long bones as well as fractures of the pelvis. The implant set is available either in stainless steel (316L) or titanium alloy (Ti6Al4V).
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 marked device.
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
AUG 3 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corportion 59 Route 17 Allendale, New Jersey 07401-1677
Re: K012162
Trade Name: Basic Fragment Set Regulation Number: 888.3030 Regulatory Class: II Product Codes: HRS, HWC Dated: July 10, 2001 Received: July 11, 2001
Dear Ms. Ariemma:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed from we free is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce suice in also 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provisions of the 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 Coorisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket rippt of ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mspoticils) also I 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.
2
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your you substantial equivalence of your device to a legally marketed nouticate 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 If you desire specific as in vitro diagnostic devices), please contact the Office of Compliance at additionally, for questions on the promotion and advertising of your device, (2017) 594-4639. Nathiendry, commission (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
b. Mark A. Milkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
3
510(k) Number (if known): Ko 2(6 س2
Device Name: Basic Fragment Set
The Basic Fragment Set is intended for use in long bone fracture fixation.
Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:
- Fractures of the femur .
- Fractures of the tibia .
- Fractures of the humerus .
- Fractures of the pelvis .
T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:
- Fractures of the femoral condyles .
- Fractures of the tibial plateau .
- Fractures of the distal tibia .
- Fractures of the proximal-humerus ●
fo Mark n Millkerson
al. Restorative
2012160 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)