(24 days)
Not Found
No
The description focuses on the mechanical properties and materials of bone plates and screws, with no mention of AI or ML.
No.
The device is clearly described as a system of plates and screws for fixing bone fractures, which is a structural or mechanical function, not a therapeutic one in the sense of treating disease or illness.
No
Explanation: The device is a plating system used for fixation of bone fractures, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the device includes bone plates and screws made from stainless steel, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the "fixation of pelvic, small and long bone fractures". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "bone plates and screws" made from stainless steel, designed to "aid in holding fracture reduction". These are implantable medical devices used in 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / 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 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, calcaneus, and clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, KTT, LXT
Device Description
The subject devices include PERI-LOC* Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws, which are line additions to and modifications to the PERI-LOC* Periarticular Locked Plating System devices previously cleared under K051735. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates, locking and 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, calcaneus, and clavicle.
Indicated Patient Age Range
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): 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.
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
510(k) Summary of Safety and Effectiveness
PERI-LOC' Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116
JUN - 8 2006 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 12, 2006 |
| Contact Person: | David Henley, Senior Regulatory Affairs Specialist
Tel: (901) 399-6487 Fax: (901) 399-1557 |
| Proprietary Name: | PERI-LOC® Periarticular Locked Plating System -
Locking Bone Plates & Screws for the Upper Extremity |
| 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
21 CFR 888.3040, smooth or threaded metallic bone
fixation fastener - Class II |
| Device Product Code and Panel Code: | HRS, HWC, KTT, LXT / Orthopedics / 87 |
Device Description:
The subject devices include PERI-LOC* Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws, which are line additions to and modifications to the PERI-LOC* Periarticular Locked Plating System devices previously cleared under K051735. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates, locking and 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 and pediatric patients, as well as 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, calcaneus, and clavicle.
Technological Characteristics:
Components comprising PERI-LOC° Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity are very similar to legally marketed devices listed below in that they share identical indications for use (compared to K051735), are manufactured from identical material, and incorporate very similar technological characteristics.
Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.
- Smith & Nephew Locked Plating System (PERI-LOC* Periarticular Locked Plating System) K033669 .
- PERI-LOC Periarticular Locked Plating System for the Upper Extremity K051735 .
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UN = 8 2006
Mr. David Henley Senior Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
/ Re:
K061352 Trade/Device Name: PERI-LOC Periarticular Locked Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: HRS, HWC, KTT, LXT Dated: May 12, 2006 Received: May 15, 2006
Dear Mr. Henley:
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
2
Page 2 - Mr. David Henley
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 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 Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson, M.S.
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): _
PERI-LOC Periarticular Locked Plating System Device Name:
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 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, calcaneus, and clavicle.
Components in the PERI-LOC* Periarticular Locked Plating System are for single use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
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)
emol
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_ko61352