(57 days)
No
The description focuses on the mechanical design and function of the screw and plate system for bone fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, which are therapeutic interventions.
No
Explanation: The device is an orthopedic implant (screws and plates) used for temporary internal fixation and stabilization of fractures, not for diagnosing medical conditions.
No
The device description clearly details a physical implantable screw made of titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MotionLoc Screws are for "temporary internal fixation and stabilization of fractures and osteotomies of long bones." This describes a surgical implant used to physically stabilize bone, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics of the screw and its function in a surgical context (locking into plates, providing fixation, reducing stiffness). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological specimen. The device's function is purely mechanical and structural within the body.
Therefore, the MotionLoc Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MotionLoc Screws, when used with the NCB Proximal Humeral or NCB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- Comminuted fractures
- Fractures in osteopenic bone
- Nonunions/Malunions
MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- Comminuted fractures
- Supracondylar fractures
- Fractures in osteopenic bone
- Nonunions/Malunions
MotionLoc Screws, when used with the NCB Straight Narrow Shaft plates, are indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:
- Periprosthetic fractures
- Comminuted fractures
- Fractures in osteopenic bone
- Nonunions/Malunions
MotionLoc Screws, when used with the NCB Periprosthetic Proximal Femur, Distal Femur or Curved Femur Shaft plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- Fractures in osteopenic bone
- Nonunions/Malunions
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The MotionLoc Screw is a member of the NCB Screw family and is used as an alternative for standard NCB Screws in applications where a surgeon desires reduced stiffness in a construct.
The MotionLoc Screw has a standard NCB Screw front thread section, a mid-section with a reduced core-diameter, a collar region, and a standard NCB Screw head for engagement in NCB locking plates. The MotionLoc Screws provide unicortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate. The NCB technology allows for polyaxial screw placement (30° cone) of the MotionLoc Screws with screw locking achieved using previously cleared Locking Caps (K042695, cleared 10/29/2004) that are threaded into the plate holes.
In the locked mode the NCB plate acts as an internal fixator without contact between the plate and the bone surface thus reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers (also previously cleared in K042695), which are threaded into the plate holes prior to plate insertion. Plates, screws, spacers and locking caps are made of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, humeral and tibial shaft, Proximal Femur, Distal Femur or Curved Femur Shaft
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance and Conclusions:
Sterilization Validation - Sterilization has not changed with the new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three. These devices have been validated to demonstrate that at a minimum gamma dose of 20kGy these screws can be terminally sterilized to a SAL of 10-6 or better.
Shelf Life - Shelf life has not changed with the new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three. Accelerated aging showed that these sterile screws have a shelf life of 10 years.
Sterile Packaging - Packaging has not changed. The sterile screws can withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
Biocompatibility - Biocompatibility testing on the screw implant materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
The new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three does not change the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.
Testing/Literature - The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices when used with the newly indicated plate and for use with three screws. Testing/analysis performed included axial fatigue strength and torsional fatigue. In addition, data from the included literature references indicates that the devices are safe and effective for the newly indicated bone quality (osteopenic).
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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.
K101696, K100111, K113718, K082807
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.
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, positioned above the word "zimmer" in a lowercase, sans-serif font. The "Z" is black, and the word "zimmer" is also black.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
K123918 510(k) Summary
page 1 of 4
FEB 14 2013
Sponsor:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Contact Person:
Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760
Date:
Trade Name:
Zimmer . MotionLoc™ Screw for NCB® Polyaxial Locking Plate System
Common Name:
Classification Names and References:
Classification Panel:
Predicate Devices:
Purpose and Device Description:
Zimmer . MotionLoc Screw for NCB Polyaxial Locking Plate
System
Bone Screw
December 18, 2012
Plate, Fixation, Bone (21 CFR 888.3030, Product Code HRS)
Orthopedics/87
The predicate devices are:
- Zimmer MotionLoc Screw For NCB Polyaxial Locking Plate . System, K101696, cleared September 10, 2010
- . Zimmer NCB Periprosthetic Femur Polyaxial Locking Plate System (K100111, cleared April 12, 2010)
- Zimmer NCB Straight Narrow Shaft Plates (K113718, cleared . January 27, 2012)
- Synthes 4.5mm Locking Compression Plate (LCP) with . Extended Indications (K082807, cleared January 13, 2009)
This submission extends the indications of the existing MotionLoc Screw for NCB Polyaxial Locking Plate System by adding to the list of compatible plates to include the NCB Periprosthetic Proximal Femur, Distal Femur, Curved Femur Shaft and Straight Narrow Shaft plates and by allowing the MotionLoc screw to be used for fractures in osteopenic bone. In addition, this submission decreases the number of required MotionLoc screws in the shaft of the bone from four to three.
1
The MotionLoc Screw is a member of the NCB Screw family and is used as an alternative for standard NCB Screws in applications where a surgeon desires reduced stiffness in a construct.
The MotionLoc Screw has a standard NCB Screw front thread section, a mid-section with a reduced core-diameter, a collar region, and a standard NCB Screw head for engagement in NCB locking plates. The MotionLoc Screws provide unicortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate. The NCB technology allows for polyaxial screw placement (30° cone) of the MotionLoc Screws with screw locking achieved using previously cleared Locking Caps (K042695, cleared 10/29/2004) that are threaded into the plate holes.
In the locked mode the NCB plate acts as an internal fixator without contact between the plate and the bone surface thus reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers (also previously cleared in K042695), which are threaded into the plate holes prior to plate insertion. Plates, screws, spacers and locking caps are made of titanium alloy.
Intended Use:
MotionLoc Screws, when used with the NCB Proximal Humeral or NCB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions/Malunions
MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Comminuted fractures
- · Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions/Malunions
MotionLoc Screws, when used with the NCB Straight Narrow Shaft plates, are indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:
2
- · Periprosthetic fractures
- · Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions/Malunions
MotionLoc Screws, when used with the NCB Periprosthetic Proximal Femur, Distal Femur or Curved Femur Shaft plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
-
· Periprosthetic fractures
-
· Comminuted fractures
-
· Supracondylar fractures
-
· Fractures in osteopenic bone
-
Nonunions/M
-
alunions
.
The physical attributes (dimensions, materials, specifications manufacturing processes, etc.) have not changed from the predicate MotionLoc Screws. They still have a standard NCB Screw front thread section, a mid-section with a reduced corediameter, a collar region, and a standard NCB Screw head for engagement in NCB locking plates. As before, these MotionLoc Screws provide unicortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate.
The NCB technology allows for polyaxial screw placement (30° cone) of the MotionLoc Screws with screw locking achieved using previously cleared Locking Caps (K042695, cleared 10/29/2004) that are threaded into the plate holes.
In the locked mode the NCB plate acts as an internal fixator without contact between the plate and the bone surface thus reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers (also previously cleared in K042695), which are threaded into the plate holes prior to plate insertion. Plates, screws, spacers and locking caps are made of titanium alloy.
The proposed device is similar in intended use to the predicate devices.
Comparison to Predicate Devices:
3
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Sterilization Validation - Sterilization has not changed with the new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three. These devices have been validated to demonstrate that at a minimum gamma dose of 20kGy these screws can be terminally sterilized to a SAL of 10° or better.
Shelf Life - Shelf life has not changed with the new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three. Accelerated aging showed that these sterile screws have a shelf life of 10 years.
Sterile Packaging - Packaging has not changed. The sterile screws can withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
Biocompatibility - Biocompatibility testing on the screw implant materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
The new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three does not change the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.
Testing/Literature - The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices when used with the newly indicated plate and for use with three screws. Testing/analysis performed included axial fatigue strength and torsional fatigue. In addition, data from the included literature references indicates that the devices are safe and effective for the newly indicated bone quality (osteopenic).
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
4
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14. 2013
Zimmer. Incorporated % Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K123918
Trade/Device Name: Zimmer® MotionLoc™ Screw for NCB® Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II Product Code: HRS Dated: December 18, 2012 Received: December 19, 2012
Dear Mr. McKelvey:
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. 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.
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
5
Page 2 - Stephen H. McKelvey, MA, RAC
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/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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/5/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The word "Erin" is in a bold, sans-serif font, while "Keith" is in a more decorative font with geometric patterns filling the letters. The overall design is simple but eye-catching due to the contrast in font styles.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K123918
Device Name:
Zimmer® MotionLoc™ Screw For NCB® Polyaxial Locking Plate System
Indications for Use:
MotionLoc Screws, when used with the NCB Proximal Humeral or NCB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions/Malunions
MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Comminuted fractures
- · Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions/Malunions
MotionLoc Screws, when used with the NCB Straight Narrow Shaft plates, are indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:
- · Periprosthetic fractures
- · Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions/Malunions
MotionLoc Screws, when used with the NCB Periprosthetic Proximal Femur, Distal Femur or Curved Femur Shaft plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- · Comminuted fractures
- · Supracondylar fractures
- · Fractures in osteopenic bone
- Nonunions/Malunions
Prescription Use X (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)
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- Division of Orthopedic Devices