(86 days)
The NCB® Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
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.
The provided document (K101696) describes a 510(k) premarket notification for the "MotionLoc™ Screw for NCB® Polyaxial Locking Plate System."
Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to predicate devices through qualitative and comparative non-clinical performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (comparable to predicate devices) | "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." |
| Mechanical Performance (e.g., fatigue, torque characteristics) | "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)." The outcomes of these tests are stated to have demonstrated no new issues regarding safety and effectiveness compared to predicate devices, implying acceptable performance in these areas. |
| Biocompatibility (implied, as materials are similar) | While not explicitly detailed as a separate test, the statement "The MotionLoc Screw for NCB Polyaxial Locking Plate System is similar in intended use, materials, sterility, and performance characteristics to the predicate devices" implies that the materials (titanium alloy for plates, screws, spacers, and locking caps) are considered safe and biocompatible, consistent with the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Non-clinical Performance Data):
- Sample Size: The document does not provide specific sample sizes (e.g., number of constructs or screws tested) for the non-clinical fatigue, torque, or animal studies. It mentions "Construct fatigue testing," "Starting load, driving torque and torque to failure testing," and "Animal testing in an ovine tibial osteotomy model," but not the 'n' for each.
- Data Provenance: The data is non-clinical (lab and animal testing). The country of origin is not explicitly stated, but given Zimmer, Inc. is based in Warsaw, Indiana, USA, it's reasonable to infer the testing was conducted in the USA or under US regulatory standards. The data is retrospective in the sense that it was generated for the purpose of this submission and presented as completed studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the provided document pertains to a medical device's physical and mechanical performance evaluation (non-clinical testing) for substantial equivalence, not the evaluation of an algorithm or diagnostic device requiring expert interpretation of a test set to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a bone screw system, not a diagnostic imaging or AI-assisted interpretation device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance studies, the "ground truth" was established by engineering and biomechanical principles and measurements against recognized standards (implied by the FDA's regulatory framework for mechanical performance) and comparison to the predicate device's established performance parameters. For the animal study, the outcome in the ovine model would serve as the "ground truth" for assessing biological response and initial fixation properties. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic study of a disease.
8. The Sample Size for the Training Set
This information is not applicable as there is no mention of a "training set" for an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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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.
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| The NCB technology allows for polyaxial screwplacement (30° cone) of the MotionLoc Screws withscrew locking achieved using previously,cleared LockingCaps (K042695, cleared 10/29/2004) that are threadedinto the plate holes. | |
|---|---|
| In the locked mode the NCB plate acts as an internalfixator without contact between the plate and the bonesurface thus reducing the risk of periosteal blood supplyimpairment. This Non-Contact Bridging concept can bespecifically controlled through the use of 1, 2, or 3mmspacers (also previously cleared in K042695), which arethreaded into the plate holes prior to plate insertion.Plates, screws, spacers and locking caps are made oftitanium alloy. | |
| Intended Use: | The NCB Polyaxial Locking Plate System is indicated fortemporary internal fixation and stabilization of fracturesand osteotomies of long bones. |
| Comparison to Predicate Device: | The MotionLoc Screw for NCB Polyaxial Locking PlateSystem is similar in intended use, materials, sterility, andperformance characteristics to the predicate devices. Seethe device description above for the design differencesbetween the proposed and predicate devices. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions: |
| The results of non-clinical (lab and animal) performancetesting demonstrate that the MotionLoc Screw for theNCB Polyaxial Locking Plate System presents no newissues regarding safety and effectiveness as compared tothe predicate devices, and is substantially equivalent.Testing/analysis performed included: Construct fatiguetesting (Distal Femur Plate with MotionLoc Screws ,Proximal Tibia Plate with MotionLoc Screws ); Startingload, driving torque and torque to failure testing( MotionLoc Screws ); and Animal testing in an ovinetibial osteotomy model (locking compression plate withprototype MotionLoc Screws ). | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for thisdevice. |
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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
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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
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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
11
§ 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.