(86 days)
No
The description focuses on the mechanical properties and design of the bone plate system and screws, with no mention of AI or ML for analysis, planning, or any other function.
No
The device is an internal fixation system for fractures and osteotomies, which is a structural support rather than a therapeutic treatment.
No
The device is described as a system for temporary internal fixation and stabilization of fractures and osteotomies of long bones, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components made of titanium alloy (plates, screws, spacers, locking caps) used for internal fixation of bones. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a system for temporary internal fixation and stabilization of fractures and osteotomies of long bones. This is a surgical implant used directly within the body to support bone healing.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device interacts directly with the bone.
Therefore, based on the provided information, the NCB® Polyaxial Locking Plate System and its components are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The NCB® Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The MotionLoc Screw for Polyaxial NCB Locking Plate System is used in conjunction with the NCB Polyaxial Locking Plate System. It 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 for Polyaxial NCB Locking Plate System 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
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:
The results of non-clinical (lab and animal) performance testing demonstrate that the MotionLoc Screw for the NCB Polyaxial Locking Plate System presents no new issues regarding safety and effectiveness as compared to the predicate devices, and is substantially equivalent. Testing/analysis performed included: Construct fatigue testing (Distal Femur Plate with MotionLoc Screws , Proximal Tibia Plate with MotionLoc Screws ); Starting load, driving torque and torque to failure testing (MotionLoc Screws ); and Animal testing in an ovine tibial osteotomy model (locking compression plate with prototype MotionLoc Screws ).
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.
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
§ 888.3040 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
PG. 1/2
SEP 1 0 2010
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a sans-serif font.
Summary of Safety and Effectiveness
Sponsor:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Stephen McKelvey Senior Project Manager, Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 372-4605 -
Date:
Trade Name:
Contact Person:
Common Name:
Classification Name and Reference:
Predicate Device:
Device Description:
September 1, 2010
MotionLoc™ Screw for NCB® Polyaxial Locking Plate System
Bone Screw
Screw, Fixation, Bone 21 CFR § 888.3040
NCB Plating System, K042695, cleared October 29, 2004; NCB Plating System, Proximal Tibial Plates, K061211, cleared June 14, 2006; NCB Plating System, Proximal Humeral Plates, K081759, cleared October 16, 2008.
The MotionLoc Screw for Polyaxial NCB Locking Plate System is used in conjunction with the NCB Polyaxial Locking Plate System. It 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 for Polyaxial NCB Locking Plate System 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.
1
| | 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: | The NCB Polyaxial Locking Plate System is indicated for
temporary internal fixation and stabilization of fractures
and osteotomies of long bones. |
| Comparison to Predicate Device: | The MotionLoc Screw for NCB Polyaxial Locking Plate
System is similar in intended use, materials, sterility, and
performance characteristics to the predicate devices. See
the device description above for the design differences
between the proposed and predicate devices. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | The results of non-clinical (lab and animal) performance
testing demonstrate that the MotionLoc Screw for the
NCB Polyaxial Locking Plate System presents no new
issues regarding safety and effectiveness as compared to
the predicate devices, and is substantially equivalent.
Testing/analysis performed included: Construct fatigue
testing (Distal Femur Plate with MotionLoc Screws ,
Proximal Tibia Plate with MotionLoc Screws ); Starting
load, driving torque and torque to failure testing
( MotionLoc Screws ); and Animal testing in an ovine
tibial osteotomy model (locking compression plate with
prototype MotionLoc Screws ). |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for this
device. |
.
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:
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2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem resembling an abstract bird or human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Stephen McKelvey Senior Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
SEP 1 0 2010
Re: K101696
Trade/Device Name: MotionLoc™ Screw for NCB® Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II · Product Code: HWC, HRS Dated: June 15, 2010
Received: June 16, 2010
Received: June 19, 2010
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, 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.
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. Stephen McKelvey
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.fdaggv/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Daulave Bnehup
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K101696 510(k) Number (if known):
Device Name:
MotionLoc" Screw for NCB® Polyaxial Locking Plate System
Indications for Use:
The NCB® Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
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)
Ondate for mxm
(Dision Sign-9 Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101696
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SEP 1 0 2010
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