(61 days)
No
The device description and intended use focus on mechanical components (plates and screws) for fracture fixation, with no mention of software, algorithms, or AI/ML terms.
Yes
The device, a plating and screw system, is designed to fix bone fractures, which is a therapeutic intervention.
No
The device is described as a plating system, including bone plates and screws, used for the fixation of bone fractures. Its purpose is to physically stabilize fractures, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a system of bone plates and screws made from stainless steel, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of pelvic, small and long bone fractures". This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "contoured locking bone plates and locking/non-locking bone screws". These are physical implants used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used for fracture fixation.
N/A
Intended Use / Indications for Use
The PERI-LOC™ Periarticular Locked Plating System can be used for adult patients with osteopenic bone. PERI-LOC™ bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, and clavicle.
The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
Product codes
HRS, HWC
Device Description
Volar Distal Radius Locking Plates for the Upper Extremity manufactured from ASTM F139 material are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, and clavicle (also calcaneus in the Indications for Use Statement)
Indicated Patient Age Range
adult patients, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051735, K061352, K033669, K071563
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
510(k) Summary of Safety and Effectiveness
PERI-LOC™ Periarticular Locked Plating System
Volar Distal Radius Locking Plate for the Upper Extremity - ASTM F139 Material Change
| Submitted By: | Smith & Nephew, Inc.,
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 | JUN 1 8 2008 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | February 13, 2008 | |
| Contact Person: | Laura Sejnowski, Regulatory Affairs Specialist
Tel: (901) 399-5349 Fax: (901) 399-1557 | |
| Proprietary Name: | PERI-LOC™ Periarticular Locked Plating System -
Volar Distal Radius Locking Plate for the Upper Extremity
ASTM F139 Material Change | |
| Common Name: | Bone Plates and Bone Screws | |
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple component metallic bone
fixation appliances and accessories - Class II | |
| Device Product Code and Panel Code: | HRS, HWC / Orthopedics / 87 | |
Device Description:
Volar Distal Radius Locking Plates for the Upper Extremity manufactured from ASTM F139 material are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
Intended Use:
The PERI-LOC™ Periarticular Locked Plating System can be used for adult patients with osteopenic bone. PERI-LOC™ bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, and clavicle.
Technological Characteristics:
PERI-LOC™ Volar Distal Radius Plates manufactured from ASTM F139 material are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics.
Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition.
- . PERI-LOC™ Periarticular Locked Plating System for the Upper Extremity - K051735
- . PERI-LOC™ Periarticular Locked Plating System for the Upper Extremity Device Modifications – K061352
- . Smith & Nephew Locked Plating System (PERI-LOC™ Periarticular Locked Plating System) – K033669
- . PERI-LOC™ Periarticular Locked Plating System VLP Plates/Screws – K071563
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Orthopaedic Division Ms. Laura Sejnowski Regulatory Affairs Specialist 1450 Brooks Road Memphis, TN 38116
JUN 1 8 2008
Re: K081106 Trade/Device Name: Peri-Loc™ Periarticular Locked Plating System - Volar Distal Radius Locking Plate for the Upper Extremity Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 15, 2008 Received: May 19, 2008
Dear Ms. Sejnowski:
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
2
Page 2 - Ms. Laura Sejnowski
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.
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 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Indications for Use Statement
510(k) Number (if known): ___ K 0 8 || 0 6
PERI-LOC™ Periarticular Locked Plating System -Device Name: Volar Distal Radius Locking Plate for the Upper Extremity - ASTM F139 Material Change
Indications for Use:
The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
Components in the PERI-LOC™ Periarticular Locked Plating System are for single use only.
Prescription Use × AND/OR (Part 21 CFR 801.109)
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General, Restorative, and Neurological Devices
510(k) Number K091106