(84 days)
No
The summary describes a mechanical bone plating system and does not mention any AI or ML components.
No.
The device is a bone plate and screw system intended for internal fixation of fractures and osteotomies of the proximal femur, which are structural and mechanical functions, not therapeutic in the sense of treating a disease or condition through non-mechanical means.
No
The device, PERI-LOC™ Periarticular Locked Plating System, is an orthopedic implant used for fixation of fractures and osteotomies of the proximal femur. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "Periarticular Locked Plating System – Proximal Femur Locking Bone Plates manufactured from titanium material" and mentions "locking bone plates" and "screw-to-plate locking feature," indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device's application in fixing bone fractures and osteotomies in the proximal femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as bone plates, screws, and cable accessories made from titanium material, designed to be implanted to stabilize bone fractures. This is a medical device used for internal fixation.
- 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 surgical repair.
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; basiltranscervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
Product codes
HRS, HWC
Device Description
The subject PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates manufactured from titanium material have undergone a design modification when compared to devices cleared under K072818. Like the predicate devices include various lengths of contoured, locking bone plates made from titanium material. PERI-LOC™ Proximal Femur locking bone plates incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction. The subject implant devices will be available in the following configurations:
PERI-LOC 4.5mm Lateral Proximal Femur Locking Plate, LH
Number of Individual Locking Screw Holes Per Plate: 2, 4, 6, 9, 12, 15 or 18
PERI-LOC 4.5mm Lateral Proximal Femur Locking Plate, RH
Number of Individual Locking Screw Holes Per Plate: 2, 4, 6, 9, 12, 15 or 18
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 as well as patients with osteopenic bone.
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)
Pre-clinical bench testing was conducted on the subject devices (that have undergone the design modification) in comparison against previously cleared TC-100 Blade Plates described above. The specific type of pre-clinical testing conducted is described as: Construct fatigue testing of bone plate (and screw) constructs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K112406 (pg1/2)
PERI-LOC™ Periarticular Locked Plating System Proximal Femur Locking Bone Plates
NOV 1 4 2011
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------|
| Date: | August 19, 2011 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager
Tel: (901) 399-6487 Fax: (901) 566-7079 |
| Proprietary Name: | PERI-LOC ™ Periarticular Locked Plating System -
Proximal Femur Locking Bone Plates |
| Common Name: | Bone Plates |
| 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 / Orthopedics / 87 |
Device Description:
The subject PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates manufactured from titanium material have undergone a design modification when compared to devices cleared under K072818. Like the predicate devices include various lengths of contoured, locking bone plates made from titanium material. PERI-LOC™ Proximal Femur locking bone plates incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction. The subject implant devices will be available in the following configurations:
| Device Type | Devices Available With the
Following Number of
Individual Locking Screw
Holes Per Plate |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| PERI-LOC 4.5mm Lateral Proximal Femur Locking Plate, LH | 2, 4, 6, 9, 12, 15 or 18 |
| PERI-LOC 4.5mm Lateral Proximal Femur Locking Plate, RH | 2, 4, 6, 9, 12, 15 or 18 |
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; basiltranscervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
11,
1
Technological Characteristics:
Components comprising PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates are similar to legally marketed devices listed below in that they share identical or similar indications for use, are manufactured from titanium material (i.e. devices cleared under K072818). and incorporate identical or similar technological characteristics.
Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on identical or similar design features, overall indications for use, and material composition.
- . PERI-LOC™ Proximal Femur Locking Bone Plates (Bone Screws and Cable Accessories) - K072818
- . (Smith & Nephew) Trauma Internal Fixation System (TC-100 Blade Plates) - K993289
To further support a determination of substantial equivalence, pre-clinical bench testing was conducted on the subject devices (that have undergone the design modification) in comparison against previously cleared TC-100 Blade Plates described above. The specific type of pre-clinical testing conducted is described as:
- Construct fatigue testing of bone plate (and screw) constructs .
O
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract eagle-like symbol with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew Inc. Orthopaedics Division % David Henly 7135 Goodlet Farms Parkway Cordova, Tennessee 38016
NOV 1 4 2011
Re: K112406
Trade/Device Name: PERI-LOC™ Periarticular Locked Plating System -Proximal Femur Locking Bone Plates 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: August 19, 2011 Received: August 22, 2011
Dear Mr. Henly:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. David Henly
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
| 510(k) Number (if known): | K112406 (pa 1/1) |
|---|---|
| --------------------------- | ------------------ |
Device Name: PERI-LOC ™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates
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, complax nultifragmentary, 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; sub boitel, femoral neck fractures; and subtrochanteric femur fractures.
Components in the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates are for single use only.
Prescription Use × (Per 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)
OR
Concurrence of CDRH, @ffice of Device Evaluation (ODE)
t
(Division Sign-Off Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K112406