(21 days)
Not Found
No
The 510(k) summary describes a mechanical bone plating and screw system and makes no mention of AI or ML technology.
No
The device is described as a bone plating system used for the fixation of fractures, which is a structural support device rather than one that treats a disease or condition.
No
The device is a plating system used for fixation of bone fractures, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of bone plates and screws, which are hardware components, not software.
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 used for the fixation of 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, which are implants 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 screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body to treat a physical condition.
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
HRS, HWC, KTT, LXT
Device Description
PERI-LOC° Locking Bone Plates and Locking Bone Screws for the Upper Extremity are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and 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)
K033669, K041860, K033995, K000684, K041709, K012655, K050932
Reference Device(s)
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 and Locking Bone Screws for the Upper Extremity
| Submitted By: | JUL. 1 9 2005
Smith & Nephew, Inc., Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 27, 2005 |
| Contact Person: | David Henley, Senior Regulatory Affairs Specialist
Tel: (901) 399-6487 Fax: (901) 398-5146 |
| Proprietary Name: | PERI-LOC® Locking Bone Plates and Locking
Bone 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:
PERI-LOC° Locking Bone Plates and Locking Bone Screws for the Upper Extremity are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and 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 and Locking Bone Screws for the Upper Extremity 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 K033669 .
- Synthes LCP Proximal Humerus Plates K041860 .
- Synthes 3.5mm LCP Distal Humerus System K033995 .
- Synthes Small Fragment DCL System K000684 .
- Howmedica Osteonics Numelock II Polyaxial Locking System K041709 .
- Acumed, Inc. Congruent Bone Plate System K012655 .
- Hand Innovations, Inc. Distal Volar Radius Anatomical Plate System K050932 .
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.
JUL 19 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Henley Senior Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K051735 . Kool 753
Trade/Device Name: PERI-LOC® Periarticular Locked Plating System Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS, HWC, KTT, LXT Dated: June 27, 2005 Received: July 6, 2005
Dear Mr. Henley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became o ready fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to togethy the enactment date of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Free (110) was the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 world) als. Existing major regulations affecting your device can may be subject to such additions, 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 I least of advised that I Drivisation that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I ederal bather 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 OF IT in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality by tights (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to ough finding of substantial equivalence of your device to a legally prematics notification: "The Pressification 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 If you desire spochile at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Evelyn Chen
Miriam C. Provost, Ph.D. Acting 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): | K051735 |
|---|---|
| --------------------------- | --------- |
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)
Earle Orr