(103 days)
Not Found
No
The summary describes a mechanical plate and screw system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a plate and screw system for internal fracture fixation, which is a structural support rather than a device that delivers therapy.
No
This device is a surgical implant designed for internal fracture fixation, not for diagnosing medical conditions. It provides temporary internal fixation and stabilization, which is a treatment, not a diagnostic function.
No
The device description explicitly states it is a "plate and screw system intended for internal fracture fixation," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for temporary internal fixation and stabilization of osteotomies and fractures. This is a surgical procedure performed directly on the patient's body to treat a physical condition.
- Device Description: The description details a plate and screw system for internal fracture fixation. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived 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 Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
Comminuted fractures
Supracondylar fractures
Intra-articular and extra-articular condylar fractures
Fractures in osteopenic bone
Nonunions
Malunions
Product codes
HRS, HWC
Device Description
The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humeral, Ulna
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)
Non-Clinical Performance and Conclusions:
The results of non-clinical testing show the proposed device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
式() VOS 78 ﺮﺍ ﺍﻟﻤﺴﺎﺑﻘﺎ
Summary of Safety and Effectiveness
NOV = 3 2008
| Submitter: | Zimmer. Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia
Senior Associate, Regulatory Affairs
Telephone: 574-372-4570
Fax: (574) 372-4605 |
| Date: | July 22, 2008 |
| Trade Name: | Zimmer® Periarticular Locking Plate System: Distal
Humeral and Proximal Ulna Plates |
| Common Name: | Periarticular Locking Plates |
| Classification Name | Plate, Fixation, Bone; Screw, Fixation, Bone |
| and Reference: | 21 CFR § 888. 3030. 888.3040 |
| Predicate Device: | Zimmer Periarticular Locking Plate System:
Distal Lateral Fibular Plates and Screws,
K070906, cleared May 1, 2007 |
| Device Description: | The Zimmer Periarticular Locking Plate System is a
plate and screw system intended for internal
fracture fixation. The low-profile periarticular
locking plate is anatomically contoured and has
threaded holes which accept locking screws to
create a stable, fixed angle construct. |
| Intended Use: | The Periarticular Locking Plate System is indicated
for temporary internal fixation and stabilization of
osteotomies and fractures, including:
· Comminuted fractures
· Supracondylar fractures
• Intra-articular and extra-articular condylar
fractures
· Fractures in osteopenic bone
· Nonunions
· Malunions |
:
:
・・・。
: ・ ・
1
loxn 7x+12
Comparison to Predicate Device:
The Zimmer Periarticular Locking Platc System has the same intended use, has similar performance characteristics, is manufactured from identical materials using identical processes, and is similar in design to the predicate devices.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
The results of non-clinical testing show the proposed device is safe and effective.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2008
Zimmer, Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K082078 Trade/Device Name: Zimmer® Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 27, 2008 Received: October 28, 2008
Dear Mr. Francalancia:
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 - Mr. Anthony Francalancia
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
መሆኑን የሚገኝ የሚገኝ የሚገኝ የሚገኝ የሚገኝ የሚገኝ የሚገኝ የተወለደው የአማርኛ ምሳሌ ነው። ትርጉሙ ያልተተረጎመ ምሳሌ ተረት
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mikkelson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082678
Device Name:
Zimmer® Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates
Indications for Use:
The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
- · Comminuted fractures
- · Supracondylar fractures
- · Intra-articular and extra-articular condylar fractures
- · Fractures in osteopenic bone
- Nonunions
- · Malunions
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 3121 - 117 Division of General, Restorative. and Neurological Devics
Page 1 of 1
510(k) Number K082078