(73 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI/ML capabilities or data processing.
Yes
The device is described as a medical implant system used to provide temporary stabilization as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which clearly constitutes a therapeutic purpose.
No
Explanation: The device is a pedicle screw system, which consists of implants (screws, rods) and associated instrumentation used for surgical stabilization of the spine as an adjunct to fusion. Its purpose is mechanical support, not to diagnose a condition.
No
The device description explicitly states that the device consists of "various screws, rods and associated accessories" and "instrumentation to facilitate the implantation of the PathFinder NXT implants," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Pedicle Screw System" consisting of "screws, rods and associated accessories" intended for "immobilization and stabilization of spinal segments" as an "adjunct to fusion." These are physical implants and surgical tools used within the body during a surgical procedure.
- Intended Use: The intended use describes the surgical application of the device for spinal fixation and stabilization. It does not involve testing samples outside the body.
Therefore, this device falls under the category of surgical implants and instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
Product codes
NKB, MNH, MNI
Device Description
The existing, commercially available Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System ("PathFinder NXT System") consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. The PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. The PathFinder NXT System allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. The percutaneous insertion rods are for minimally invasive procedures. The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions and intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.
Additionally, the PathFinder NXT System includes instrumentation to facilitate the implantation of the PathFinder NXT implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S1 (thoracic, lumbar and sacral spine), L3 and S1 (posterior lumbosacral spine)
Indicated Patient Age Range
skeletally mature 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)
The performance testing included components of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the subject PathFinder NXT® Minimally Invasive Pedicle Screw System to be substantially equivalent to its predicate devices, PathFinder NXT® Minimally Invasive Pedicle Screw System, Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System, Synergy D2 Spinal Implant and Titanium TSRH® Spinal System (Screws).
- Bench testing (static compression bending, static torsion testing, and dynamic compression bending per ASTM F1717 and static axial grip, static torsion grip, and static flexion-extension bending per ASTM F1798) for implants, polyaxial screws, and rods confirmed the product performance of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System is suitable for its intended use.
- Cadaver lab testing of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
- Biocompatibility testing ensured the subject PathFinder NXT® Minimally Invasive Pedicle Screw System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- Sterilization. Dry Time and Cleaning testing ensured the subject PathFinder NXT® Minimally Invasive Pedicle Screw System steam sterilization, cleaning and dry time requirements and instructions are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121671, K100845, K082032, K984578, K946348
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Zimmer Spine - 510(k) - PathFinder NXT System - Section 5. 510(k) Summary
Image /page/0/Picture/3 description: The image shows a logo with the letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. The logo appears to be a trademark for a company or product. The image is in black and white.
SDIne
510(k) SUMMARY
Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System
2184052
Jonathan Gilbert
Screw System
Class III
NKB. MNH. MNI
21 CFR § 888.3070
Pedicle screw spinal system
Date of Summary Preparation:
Submitter:
September 12, 2013
Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439
Regulatory Affairs Director
Office: 952.830.6385 Fax: 952.837.6985
Spinal Pedicle Fixation
Email: Jonathan.Gilbert@Zimmer.com
Orthosis, Spinal Pedicle Fixation, For
Degenerative Disc Disease; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis,
PathFinder NXT® Minimally Invasive Pedicle
Establishment Registration Number:
Company Contact:
Trade Name:
Device Name (Common Name):
Device Classification:
Product Code(s):
Regulation Number:
Regulation Description:
Predicate Devices:
For clarification purposes, this is the initial submission for this device modification and has not previously been submitted/withdrawn via a 510(k), PMA or de novo pathway. The modified PathFinder NXT® Minimally Invasive Pedicle Screw System is claimed to be substantially equivalent to the following legally marketed predicate devices:
| PathFinder NXT® Minimally Invasive Pedicle
Screw System
Predicate Device Name | Submission
ID Number | Clearance Date |
|-------------------------------------------------------------------------------------|-------------------------|--------------------|
| PathFinder NXT® Minimally Invasive Pedicle
Screw System | K121671 | July 18, 2012 |
| PathFinder NXT® Minimally Invasive Pedicle
Screw System | K100845 | September 21, 2010 |
1
| PathFinder NXT® Minimally Invasive Pedicle
Screw System
Performance Predicate Device Name | Submission
ID Number | Clearance Date |
|-------------------------------------------------------------------------------------------------|-------------------------|-----------------|
| Sequoia® Pedicle Screw System including
SpeedLink II™ Transverse Connector System | K082032 | October 6, 2008 |
| Synergy D2 Spinal Implant | K984578 | March 23, 1999 |
| Titanium TSRH® Spinal System (Screws) | K946348 | August 7, 1995 |
Zimmer Spine - 510(k) - PathFinder NXT System - Section 5. 510(k) Summary
General Device Description:
The existing, commercially available Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System ("PathFinder NXT System") consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. The PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. The PathFinder NXT System allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. The percutaneous insertion rods are for minimally invasive procedures. The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions and intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.
Additionally, the PathFinder NXT System includes instrumentation to facilitate the implantation of the PathFinder NXT implants.
Indications for Use:
When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
Summary of Technological Characteristics:
The subject Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System shares the same technological characteristics as its predicate device, Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System. The characteristics include the same design, same materials, same range of sizes, substantially equivalent performance characteristics and the same intended use.
The subject and predicate PathFinder NXT® Minimally Invasive Pedicle Screw System both consist of polyaxial screws, titanium rods, and the instruments necessary to implant the spinal system. All implant components are made from medical grade titanium alloy (Ti6Al4V ELI) per ASTM F136 and unalloyed titanium per ASTM F67.
The PathFinder NXT® Minimally Invasive Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section above. The PathFinder NXT® Minimally Invasive Pedicle Screw System consisting of polyaxial screws and titanium rods is intended to provide temporary stabilization following surgery to fuse the spine. The subject and predicate systems are provided non-sterile, are for single use only and are intended to be removed after solid fusion has occurred.
2
Zimmer Spine - 510(k) - PathFinder NXT System - Section 5. 510(k) Summary
Summary of Performance Testing:
The PathFinder NXT® Minimally Invasive Pedicle Screw System is substantially equivalent to the predicate devices in design, materials, function and intended use.
The performance testing included components of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the subject PathFinder NXT® Minimally Invasive Pedicle Screw System to be substantially equivalent to its predicate devices, PathFinder NXT® Minimally Invasive Pedicle Screw System, Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System, Synergy D2 Spinal Implant and Titanium TSRH® Spinal System (Screws).
- Bench testing (static compression bending, static torsion testing, and dynamic . compression bending per ASTM F1717 and static axial grip, static torsion grip, and static flexion-extension bending per ASTM F1798) for implants, polyaxial screws, and rods confirmed the product performance of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System is suitable for its intended use.
- Cadaver lab testing of the subject PathFinder NXT® Minimally Invasive Pedicle Screw . System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
- Biocompatibility testing ensured the subject PathFinder NXT® Minimally Invasive Pedicle . Screw System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- Sterilization. Dry Time and Cleaning testing ensured the subject PathFinder NXT® . Minimally Invasive Pedicle Screw System steam sterilization, cleaning and dry time requirements and instructions are substantially equivalent to the predicate devices.
. Substantial Equivalence:
Zimmer Spine considers the subject PathFinder NXT® Minimally Invasive Pedicle Screw System product performance to be substantially equivalent to its predicate devices, PathFinder NXT® Minimally Invasive Pedicle Screw System and Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System because there are no changes to the product performance specifications or device functional scientific technology.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2013
Zimmer Spine, Incorporated Mr. Jonathan Gilbert Director, Regulatory Affairs 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K132884
Trade/Device Name: PathFinder NXT® Minimally Invasive Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: September 12, 2013 Received: September 13, 2013
Dear Mr. Gilbert:
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 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
4
Page 2 - Mr. Jonathan Gilbert
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Mark Nielkerson -S
. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Zimmer Spine - 510(k) - PathFinder NXT System - Section 4. Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System
Indications for Use:
When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondviolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or fordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
Prescription Use ___________ (Part 21 CFR 801 Subpart D) AND/OR
(21 CFR 801 Subpart C)
Over-the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132884