(116 days)
No
The document describes surgical instruments used to assist in the implantation of bone plates and screws. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No
This device is an accessory instrument used to assist in the implantation of plates and screws, which are therapeutic devices themselves. The instruments themselves do not provide therapy.
No.
The device is described as an "accessory device" intended to "assist in the implantation" of various plate and screw systems for fracture fixation, reconstruction, and arthrodesis. It does not perform any diagnostic function.
No
The device description explicitly states that the subject devices are "accessory devices" and "instruments" intended to assist in the implantation of plates and screws. This indicates physical tools used in a surgical procedure, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are "accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plate and Screw Systems". This describes surgical instruments used during a procedure on a patient.
- Indications for Use: The indications for use list various types of bone fractures and conditions that the associated plate and screw systems are used to treat. These are clinical conditions, not in vitro diagnostic purposes.
- Device Description: The device description details the types of instruments (Templates, Reamers, Handles, etc.) which are tools used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing information for diagnosis or treatment decisions based on laboratory results.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The devices described here are surgical tools used directly on the patient during a surgical procedure.
N/A
Intended Use / Indications for Use
Smith & Nephew Plate and Screw Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plate and Screw Systems and their cleared Indications for Use.
PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories:
Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.
The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. The PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts 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 the 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
- subtrochanteric femur fractures.
In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories 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.
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories:
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Plating System is indicated for:
- the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for:
- fixation of interarticular and extra-articular fractures and non-unions of small bones and small bone fragments;
- arthrodesis of small joints;
- bunionectomies and osteotomies;
- scraphold and other carpal bones;
- metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smith & Nephew 2.0mm QFX Screw is indicated for:
- osteotomies of the lesser metatarsals, such as Weil osteotomies, osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
Smith & Nephew Accessories, such as pins and wires, are indicated for:
- pelvic, small and long bone fracture fixation.
Smith & Nephew InterTAN CHS Limited Collapse Set Screw:
Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.
InterTAN CHS Limited Collapse Set Screw is indicated for:
- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures.
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.
- Hip osteotomy
PERI-LOC Periarticular Locked Plating System- VLP Locking Bone Plates and Locking/Non-Locking Bone Screws:
Smith & Nephew VLP Locking Bone Plates and Locking/ Non-Locking Bone Screws Instruments are accessory devices and are intended to assist in the implantation of Smith & Nephew PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for:
- partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia and for fracture fixation of the fibula
PERI-LOC VLP One-Third Tubular Locking Plates are indicated for: - fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws:
Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:
- fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones;
- treatment of the calcaneal
- hip arthrodesis
- provisional bone fixation.
Smith & Nephew Bone Plate System:
Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Plate Systems and their cleared indications for use.
Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for:
- pelvic fracture fixation
- small bone fracture fixation
- long bone fracture fixation.
Titanium Classic Compression Hip Screw System:
Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.
The Titanium Classic Compression Hip Screw System is indicated for:
- Pelvic Radius Plate- general fractures of the pelvis and acetabulum
- Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement
- One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, metatarsals, olecranon, and distal ulna
- Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and ulna
- Titanium Cortical Bone Screw- small and long bone fracture fixation
Product codes (comma separated list FDA assigned to the subject device)
HRS, HTY, HWC, JDO
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Plate and Screw Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plates and Screws and their cleared Indications for Use. Smith & Nephew Plate and Screw Systems Instruments can be organized into instrument families which are categorized as follows: Templates, Reamers, Handles, Bases, Pins, Taps, Drill Guides, Insertion or Removal, and Other Guides.
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, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, clavicle, forefoot, midfoot, hindfoot, small bones, small bone fragments, small joints, scraphold, other carpal bones, patella, ulnar styloid, capitellum, radial head, radial styloid, lesser metatarsals, phalanges, carpals of the hand, proximal femur (trochanteric region, intertrochanteric, subtrochanteric, femoral neck), distal and proximal tibia, medial malleolus, fibula, distal ulna, olecranon, calcaneus, middle hand and middle foot bones.
Indicated Patient Age Range
Adult, pediatric, adolescent (12-18 years), transitional adolescent (18-21 years).
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.
K936233, K952697, K973098, K993106, K011719, K033669, K050849, K051735, K060736, K061352, K071563, K072818, K080434, K081106, K082516, K083032, K090656, K090675, K092015, K100325
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
K123055 (pg 1/5)
JAN 2 5 2013
Contact Person and Address
Date of Summary: September 27, 2012
Bradlev Heil Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 7135 Goodlett Farms Parkway Memphis, Tennessee 38016 T (901) 399-6339
Name of Device: Plate and Screw Instruments
Common Name: Orthopaedic Surgical Instrumentation
Device Classification Name and Reference:
21 CFR 888.3010 - Bone fixation cerclage
21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories
21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
Device Class: Class II
Panel Code: Orthopaedics/87
Predicate Devices:
Pelvic Radius Plate (K936233)
Titanium Classic Compression Hip Screw System (K952697)
Compression Cerclage Gundolf CCF-GF (K973098)
Smith & Nephew Bone Plate System (Bone Plates and Screws & Accessories) (K993106) PLUS Cancellous Bone Screws (K011719)
Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (K033669) HA Coated Lag Screw (K050849)
PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity (K051735)
Smith & Nephew 6.5MM and 8.0MM Cannulated Screws (K060736)
PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K061352)
PERI-LOC Periarticular Locked Plating System (K071563)
PERI-LOC Periarticular Locked Plating System - Proximal Femoral Plates/Screws, Cable Accessories (K072818)
INTERTAN CHS Locking Plate System Proximal Femoral Plates/Screw (K080434) PERI-LOC Periarticular Locked Plating System Volar Distal Radius Locking Plate for the Upper Extremity (K081106)
PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws (K082516) PERI-LOC Bone Plating and Screw System (K083032)
INTERTAN CHS Limited Collapse Set Screw (K090656)
Smith & Nephew VLP Foot Plating, Screw System & Accessories (K090675)
PERI-LOC Periarticular Locked Plating System (K092015)
PERI-LOC Locking Hole Inserts and Cable Accessories (K100325)
1
K123055 (pg 2/5)
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Plate and Screw Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plates and Screws and their cleared Indications for Use. Smith & Nephew Plate and Screw Systems Instruments can be organized into instrument families which are categorized as follows: Templates, Reamers, Handles, Bases, Pins, Taps, Drill Guides, Insertion or Removal, and Other Guides.
Intended Use
Smith & Nephew Plate and Screw Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plate and Screw Systems and their cleared Indications for Use.
PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories
Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.
The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. The PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts 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 the 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 t
- subcapital femoral neck fractures .
- subtrochanteric femur fractures. .
In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for:
2
- 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.
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Plating System is indicated for:
-
the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including . those in the forefoot, midfoot and hindfoot.
The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for: -
fixation of interarticular and extra-articular fractures and non-unions of small bones and . small bone fragments;
-
arthrodesis of small joints; .
-
bunionectomies and osteotomies; t
-
scraphold and other carpal bones; �
-
metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial . styloid.
The Smith & Nephew 2.0mm QFX Screw is indicated for:
-
osteotomies of the lesser metatarsals, such as Weil osteotomies, osteotomies, fusions � and fractures of the phalanges, metacarpals and carpals of the hand.
Smith & Nephew Accessories, such as pins and wires, are indicated for: -
pelvic, small and long bone fracture fixation. .
Smith & Nephew InterTAN CHS Limited Collapse Set Screw
Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.
InterTAN CHS Limited Collapse Set Screw is indicated for:
3
KI23DSS (pg 4/5)
- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it . may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures. .
- Stable and unstable fractuers of the proximal femur in which medial cortex stability can . be restored.
- . Hip osteotomy
PER-LOC Periarticular Locked Plating System- V.P Locking Bone Plates and Locking/Non-Locking Bone Screws
Smith & Nephew VLP Locking Bone Plates and Locking/ Non-Locking Bone Screws Instruments are accessory devices and are intended to assist in the implantation of Smith & Nephew PER-LOC Periarticular Locked Plating Systems and their cleared indications for use.
PER-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. FEN-LOC contoured V.P Plates and Screws are indicated for:
-
partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and . proximal tibia and for fracture fixation of the fibula
PER-LOC VLP One Third Tubular Locking Plates are indicated for: -
fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws
Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:
- fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, ● metatarsals, humerus, ulna, middle hand and middle foot bones;
- treatment of the calcaneal .
- hip arthrodesis ●
- provisional bone fixation. .
Smith & Nephew Bone Plate System
Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Flate Systems and their cleared indications for use.
4
K123055 (pg 5/5)
Smith & Nephew Bone Rates, Bone Screws, and Accessories are indicated for:
- pelvic fracture fixation .
- small bone fracture fixation .
- long bone fracture fixation. .
Titanium Classic Compression Hip Screw System
Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.
The Titanium Classic Compression Hip Screw System is indicated for:
- Pelvic Radius Plate- general fractures of the pelvis and acetabulum .
- Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement .
- One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, . metatarsals, olecranon, and distal ulna
- Small Auto-Compression Plate-fracture fixation of metatarsals, metacarpals, radius, and . ulna
- . Titanium Cortical Bone Screw- small and long bone fracture fixation
Substantial Equivalence Information
The device specific instruments associated with the implant devices with which they are used are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments:
- . Share the same raw materials;
- Are manufactured though the same processes; .
- Utilize the same sterilization procedures; and .
- Have similar nature of body contact .
The Smith & Nephew Plate and Screw Systems Instruments are similar in design and function to competing plate and screw surgical instrumentation on the market.
5
Image /page/5/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 or bird-like figure with outstretched wings, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 25, 2013
Smith & Nephew, Incorporated % Mr. Bradlev Heil Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K123055
Trade/Device Name: PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Smith & Nephew InterTAN CHS Limited Collapse Set Screw
PERI-LOC Periarticular Locked Plating System - VLP Locking Bone Plates and Locking/Non-Locking Bone Screws
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws Smith & Nephew Bone Plate System
Titanium Classic Compression Hip Screw System
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories - ·
Regulatory Class: Class II
Product Code: HRS, HTY, HWC, JDO
Dated: September 27, 2012
Received: November 2, 2012
Dear Mr. Heil:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
6
Page 2 - Mr. Bradley Heil
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 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/CDRH0ffices/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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known): K 123055 (ps) 7)
Device Name: PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Indications for Use:
Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.
The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. The PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts 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 the 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 .
- subtrochanteric femur fractures. .
In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories 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:
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page ੀ
Michael C. Owens 2013.01.23 17:54:30 -05'00'
8
510(k) Number (if known):
Device Name: Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Indications for Use:
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP Plating System is indicated for:
-
the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including . those in the forefoot, midfoot and hindfoot.
The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for: -
fixation of interarticular and extra-articular fractures and non-unions of small bones and . small bone frağments;
-
arthrodesis of small joints; .
-
bunionectomies and osteotomies; .
-
scraphold and other carpal bones; .
-
metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial . styloid.
The Smith & Nephew 2.0mm QFX Screw is indicated for:
-
osteotomies of the lesser metatarsals, such as Weil osteotomies, osteotomies, fusions . and fractures of the phalanges, metacarpals and carpals of the hand.
Smith & Nephew Accessories, such as pins and wires, are indicated for: -
pelvic, small and long bone fracture fixation.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens
Page
2013.01.23 17:54:09 -05'00' Division of Orthopedic Devices
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510(k) Number (if known): K123055
Device Name: Smith & Nephew InterTAN CHS Limited Collapse Set Screw Indications for Use:
Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.
InterTAN CHS Limited Collapse Set Screw is indicated for:
- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it . may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures. .
- Stable and unstable fractuers of the proximal femur in which medial cortex stability can be restored.
- Hip osteotomy
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens 2013.01.23 17:53:33 -05'00'
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510(k) Number (if known): K123055( pg 417
Device Name: PERI-LOC Periarticular Locked Plating System- VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Indications for Use:
Smith & Nephew VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Instruments are accessory devices and are intended to be used to assist in the implantation of incirations of the new PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for:
-
partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and . proximal tibia and for fracture fixation of the fibula
PERI-LOC VLP One-Third Tubular Locking Plates are indicated for: -
fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal . ulna, olecranon, calcaneus and metatarsals.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens
2013.01.23 17:53:09 -05'00'
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510(k) Number (if known): K123055(pg5/7)
Device Name: Smith & Nephew 6.5mm and 8.0mm Cannulated Screws Indications for Use:
Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:
- fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, . metatarsals, humerus, ulna, middle hand and middle foot bones;
- treatment of the calcaneal .
- hip arthrodesis .
- provisional bone fixation. ●
| Prescription Use | AND/OR | Over-The-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Please DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens 2013.01.23 17:52:48 -05'00'
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12
510(k) Number (if known): K123055(pg
Device Name: Smith & Nephew Bone Plate System Indications for Use:
Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be Smith & Reprior Bone Plate of Smith & Nephew Bone Plate Systems and their cleared indications for use.
Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for:
- pelvic fracture fixation .
- small bone fracture fixation
- long bone fracture fixation.
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens 2013.01.23 17:52:28 -05'00'
Division of Orthopedic Devices
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510(k) Number (if known):
Device Name: Titanium Classic Compression Hip Screw System Indications for Use:
Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory Smith & Nophen intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.
The Titanium Classic Compression Hip Screw System is indicated for:
-
Pelvic Radius Plate- general fractures of the pelvis and acetabulum .
12305 -
Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement .
-
One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, .
-
metatarsals, olecranon, and distal ulna ー・
-
Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and . ulna
-
Titanium Cortical Bone Screw- small and long bone fracture fixation
AND/OR Over-The-Counter Use Prescription Use X . (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens 2013.01.23 17:51:59 -05'00'
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