(48 days)
Not Found
No
The document describes a mechanical plating system for bone fractures and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a plating system used for internal fixation of bone fractures and osteotomies, which is a supportive and stabilizing function, not a therapeutic treatment.
No
Explanation: The device is described as a plating system for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states it includes bone plates, bone screws, and cable accessories made from stainless steel and titanium, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to fix fractures and perform osteotomies in the proximal femur. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as bone plates, bone screws, and cable accessories made of stainless steel and titanium, designed to be implanted in the body. This is consistent with a surgical implant.
- 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 diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
PERI-LOC™ Periarticular Locked Plating System -- Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories 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 lengths of contoured locking bone plates and locking/non-locking bone screws made from stainless steel and titanium. PERI-LOC™ Proximal Femur 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
proximal femur
Indicated Patient Age Range
adult 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): 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.
K033669, K993289, K060736, K030858
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
K072818
ess
510(k) Summary of Safety and Effective PERI-LOC™ Periarticular Locked Plating System Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories
| Submitted By: | Smith & Nephew, Inc., Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | NOV 19 2007
October 1, 2007 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager
Tel: (901) 399-6487 Fax: (901) 399-1557 |
| Proprietary Name: | PERI-LOC™ Periarticular Locked Plating System -
Proximal Femur Locking Bone Plates, Bone
Screws and Cable Accessories |
| 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 / Orthopedics / 87 |
Device Description:
PERI-LOC™ Periarticular Locked Plating System -- Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories 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 lengths of contoured locking bone plates and locking/non-locking bone screws made from stainless steel and titanium. PERI-LOC™ Proximal Femur 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:
PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
Technological Characteristics:
Components comprising PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories 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.
- Smith & Nephew Bone Plate System (TC-100 Plating System) Blade Plates K993289 .
- . PERI-LOCTM Periarticular Locked Plating System - K033669
- Smith & Nephew 6.5mm and 8.0mm Cannulated Screws K060736 .
- Synthes (USA) LCP Proximal Femur Plate and Screws K030858 .
Image /page/0/Picture/15 description: The image shows a series of vertical black and white bars, resembling a barcode. The bars vary in width and spacing, creating a distinct pattern. The image is high contrast, with sharp transitions between the black and white areas. The barcode appears to be partially damaged or distorted.
1
Premarket Notification Indications for Use Statement
510(k) Number (if known): K072818_
PERI-LOC™ Periarticular Locked Plating System -Device Name: Proximal Femur Bone Plates, Bone Screws and Cable Accessories
Indications for Use:
PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone: fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
Components in the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Bone Plates and Bone Screws are for single use only.
X X Over-the-Counter Use Prescription Use (Part 21 CFR 801.109) (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)
Image /page/1/Picture/9 description: The image shows a barcode. The barcode consists of a series of vertical black bars of varying widths, separated by white spaces. The bars and spaces are arranged in a specific pattern that represents data, which can be read by a barcode scanner. The barcode appears to be a standard linear barcode.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NDV 1 9 2007
Smith & Nephew, Inc., Orthopaedic Division % Mr. David Henley 1450 Brooks Road Memphis, TN 38116
Re: K072818
Trade/Device Name: PERI-LOC™ Periarticular Locked Plating System -- Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories 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 1, 2007 Received: October 2, 2007
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. Iisting 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 mav 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 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.
3
Page 2 – Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your he FDA finding of substantial equivalence of your device to a legally promative noticated with 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, presse 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,
Sincerely yours,
Ararbare, Buchu
ra
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number (if known): K072818____________________________________________________________________________________________________________________________________________
PERI-LOC™ Periarticular Locked Plating System -Device Name: Proximal Femur Bone Plates, Bone Screws and Cable Accessories
Indications for Use:
PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
Components in the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Bone Plates and Bone Screws are for single use only.
Over-the-Counter Use AND/OR X Prescription Use (Part 21 CFR 801.109) (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)
Chubermueno
Division of General, Restorative, and Neurological Devices
510(k) Number K072818
Image /page/4/Picture/12 description: The image shows a barcode. The barcode consists of a series of vertical black bars of varying widths, separated by white spaces. The bars and spaces are arranged in a specific pattern to represent data that can be read by a barcode scanner.