(15 days)
No
The document describes a mechanical bone plating and screw system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for fixation of fractures, which is a supportive and stabilizing function, not a direct therapeutic treatment of disease or condition.
No
The device, the PERI-LOC Periarticular Locked Plating System, is described as a surgical implant (bone plates and screws) used for fixation of bone fractures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it includes 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 procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples.
- Device Description: The description details bone plates and screws, which are implants used to stabilize fractures. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a disease or condition.
Therefore, the PERI-LOC Periarticular Locked Plating System is a surgical implant, not an In Vitro Diagnostic device.
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 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
HWC
Device Description
Hexalobular Bone Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669, K051735, K061352, and K993106. Like the predicate devices listed below, the subject components include various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws made from stainless steel that are intended for use with locking bone plates for both the upper and lower extremity. The subject screws are designed for use with the PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming 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
Prescription Use
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, K993106
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K082516 pg 1 et 1
510(k) Summary of Safety and Effectiven PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws
| Submitted By: | Smith & Nephew, Inc.,
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 | SEP 1 7 2008 |
|-------------------------------------|-------------------------------------------------------------------------------------------|--------------|
| Date: | August 28, 2008 | |
| Contact Person: | Laura Sejnowski, Regulatory Affairs Specialist
Tel: (901) 399-5349 Fax: (901) 399-1557 | |
| Proprietary Name: | PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws | |
| Common Name: | Bone Screws | |
| Classification Name and Reference: | 21 CFR 888.3040 - Screw, Fixation, Bone - Class II | |
| Device Product Code and Panel Code: | HWC / Orthopedics / 87 | |
Device Description:
Hexalobular Bone Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669, K051735, K061352, and K993106. Like the predicate devices listed below, the subject components include various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws made from stainless steel that are intended for use with locking bone plates for both the upper and lower extremity. The subject screws are designed for use with the PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming 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™ Hexalobular Bone Screws 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
- Smith & Nephew Bone Plate System (TC-100 Plate & Screw System) K993106 .
- ◆ Synthes 3.5mm Cortex Screws - K043185
1
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2008
Smith & Nephew, Inc. % Ms. Laura Sejnowski Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K082516
Trade/Device Name: PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 29, 2008 Received: September 2, 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 Foold, Orug, 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 af 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 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.
2
Page 2 - Ms. Laura Sejnowski
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 this, 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 Riometric'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. Millican
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):
PERI-LOC™ Periarticular Locked Plating System Device Name: Hexalobular Bone Screws
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 × (Part 21 CFR 801.109)
AND/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)
Del
Division of General, Restorative, and Neurological Dev
510(k) Number K082516