(89 days)
No
The device description and intended use clearly define the device as mechanical implants (locking hole inserts and cable accessories) used in conjunction with bone plating systems. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The modifications described are purely mechanical design changes.
Yes.
The device is part of a system intended for fixation of bone fractures and osteotomies, which are therapeutic interventions.
No
The device is an orthopedic implant system (plates, screws, and accessories) used for the fixation of bone fractures and osteotomies, which are therapeutic rather than diagnostic actions.
No
The device description clearly states that the device is made from 316L stainless steel and describes physical components like "Locking Hole Inserts" and "Cable Accessories," indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures and related conditions within the body. This is an in-vivo application (within a living organism).
- Device Description: The device is described as being made from 316L stainless steel and used in conjunction with bone plates and screws. These are all components used in surgical procedures on the body.
- 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.
Therefore, the PERI-LOC Locking Hole Inserts and Cable Accessories are medical devices used for surgical fixation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:
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.
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. 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 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 are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
Product Code: HWC
Device Description
Subject of this premarket notification are PERI-LOC™ Locking Hole Inserts and Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periaticular Locked Plating System cleared under K033669, K051735, K072818, and K082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in coniunction with various PERI-LOC locking bone plates for the upper and lower extremities. The subject devices are made from 316L stainless steel.
When compared to the predicate PERI-LOC Screw Hole Plug and Cable Saddles, the subject PERI-LOC Locking Hole Inserts and Cable Saddles have been modified as follows:
- Designed to be used independently or in conjunction with one another .
- Addition of a Hexalobular drive feature .
- Addition of a 3.5mm Locking Hole Insert .
The subject devices are available in the following size ranges:
| Device Type | Available Drive Feature |
|---|---|
| 3.5mm Locking Hole Insert | Hex or Hexalobular |
| 4.5mm Locking Hole Insert | Hex or Hexalobular |
| Short Cable Saddle | Hex or Hexalobular |
| Tall Cable Saddle | Hex or Hexalobular |
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, trochanteric region, proximal femur, femoral neck, subtrochanteric femur
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)
Pre-clinical testing was conducted on the subject devices. Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices.
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, K051735, K072818, K082516
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
§ 888.3040 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
K100325 (pg 1/2)
510(k) Summary of Safety and Effectiveness PERI-LOC™ Locking Hole Inserts and Cable Accessories
| Submitted By: | Smith & Nephew, Inc.,
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|----------------------------------------------|----------------------------------------------------------------------------------------|
| Date: | May 4, 2010
MAY - 4 2010 |
| Contact Person: | Laura Medlin, Regulatory Affairs Specialist
Tel: (901) 399-5349 Fax: (901) 398-5146 |
| Proprietary Name: | PERI-LOC™ Locking Hole Inserts and Cable
Accessories |
| Common Name: | Locking Bone Plate Accessories |
| Classification Name and Reference: | 21 CFR 888.3040, smooth or threaded metallic bone
fixation fastener, Class II |
| Device Classification for Predicate Devices: | 21 CFR 888.3040, smooth or threaded metallic bone
fixation fastener, Class II |
| Device Product Code and Panel Code: | Panel: Orthopedics / 87
Product Code: HWC |
Device Description:
Subject of this premarket notification are PERI-LOC™ Locking Hole Inserts and Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periaticular Locked Plating System cleared under K033669, K051735, K072818, and K082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in coniunction with various PERI-LOC locking bone plates for the upper and lower extremities. The subject devices are made from 316L stainless steel.
When compared to the predicate PERI-LOC Screw Hole Plug and Cable Saddles, the subject PERI-LOC Locking Hole Inserts and Cable Saddles have been modified as follows:
- Designed to be used independently or in conjunction with one another .
- Addition of a Hexalobular drive feature .
- Addition of a 3.5mm Locking Hole Insert .
The subject devices are available in the following size ranges:
| Device Type | Available Drive Feature |
|---|---|
| 3.5mm Locking Hole Insert | Hex or Hexalobular |
| 4.5mm Locking Hole Insert | Hex or Hexalobular |
| Short Cable Saddle | Hex or Hexalobular |
| Tall Cable Saddle | Hex or Hexalobular |
Intended Use:
PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:
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, metatarsals, humerus, ulna, radius, calcaneus, and clavicle,
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. PERI-
1
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 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 are for single use only.
Technological Characteristics:
The PERI-LOC Locking Hole Inserts and Cable Accessories are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from identical material, and incorporate similar technological characteristics.
Performance Data
To further support a determination of substantial equivalence, pre-clinical testing was conducted on the subject devices. Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices.
Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features and overall indications for use.
- Smith & Nephew Locking Bone Plate System (PERI-LOC Periarticular Locked Plating System) K033669 .
- PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity K051735 .
- PERI-LOC Periarticular Locked Plating System for the Upper Extremity K061352 ●
- PERI-LOC Periarticular Locked Plating System Proximal Femur Plates, Screws, and Cable . Accessories - K072818
- PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws K082516 .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew Inc. % Laura Medlin 1450 Brooks Rd. Memphis, Tennessee 38116
MAY - 4 2010
Re: K100325
Trade/Device Name: PERI-LOC Locking Hole Inserts and Cable Accessories Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 1, 2010 Received: February 4, 2010
Dear Ms. Medlin:
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, Orve 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 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 – Ms. Laura Medlin
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 yours,
[signature]
Mark N. Melke 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): _KIOO325(pg 1/1)
Device Name: PERI-LOC™ Locking Hole Inserts and Cable Accessories
Indications for Use:
PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:
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.
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. 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 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 are for single use only.
AND/OR Prescription Use (Part 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onetta for mums
(Division Sign-Q Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number /Cl00325
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