(180 days)
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No
The document describes a mechanical pedicle screw system and its instrumentation. There is no mention of AI, ML, image processing, or any software-based analytical capabilities that would suggest the use of AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device, a pedicle screw system, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. This function directly aims to treat medical conditions, fitting the definition of a therapeutic device.
No.
The device description clearly states that the system "is intended to provide temporary stabilization following surgery to fuse the spine" and "is intended only to provide stabilization during the development of a solid fusion with autograft or allograft." This indicates a therapeutic or supportive function rather than a diagnostic one. The "Intended Use / Indications for Use" section also lists various conditions for which the device provides fixation, not diagnosis.
No
The device description explicitly details physical components like screws, rods, and instrumentation for surgical procedures, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "Pedicle Screw System" consisting of "polyaxial cannulated screws and rods." These are implants intended for surgical insertion into the spine.
- Intended Use: The intended use is for "immobilization and stabilization of spinal segments" as an "adjunct to fusion." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When intended for pedicle screw fixation from TI-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, 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 solid fusion is established.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
The purpose of this 510(k) submission is to modernize the existing PathFinder Pedicle Screw System. A set of percutaneous insertion rods and new instrumentation have been included for minimally invasive procedures.
The Zimmer Spine PathFinder II system consists of polyaxial cannulated screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine. A range of spinal rod lengths included in this system allows the surgeon to place polyaxial pedicle screws through an open or mini-open procedure. This system is intended only to provide stabilization during the development of a solid fusion with autograft or allograft. These implants are intended to be removed after the development of a solid fusion mass.
The predicate device, Sequoia Pedicle Screw System and the proposed PathFinder II device are fabricated from medical grade titanium alloy per ASTM F136 and commercially pure titanium per ASTM F67.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
For a determination of substantial equivalence, the following non-clinical mechanical tests were performed:
Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717 were performed on the proposed PathFinder II system and predicate Sequoia Pedicle Screw system and the results compared. The proposed device functioned as intended and the observed test results demonstrate substantial equivalence to the aforementioned predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized "Z" inside it, above the words "zimmer" and "spine", with the word "spine" underlined. The text is in a bold, sans-serif font.
510(K) SUMMARY PathFinder® II Minimally Invasive Pedicle Screw System
| Company/Address: | Zimmer Spine, Inc.
5301 Riata Park Court, Bldg F
Austin, TX. 78727
Telephone: (512) 533-1998
Fax: (512) 258-0995 | | SEP 21 2010 |
|------------------|------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Contact Person: | David Padgett, RAC (US)
Senior Regulatory Affairs Specialist | | |
| Date Prepared: | 17 June 2010 | | |
Device Identification
Proprietary Name: Common Name: Classification:
PathFinder® II Minimally Invasive Pedicle Screw System Spinal Fixation System NKB - 21 CFR § 888.3070 - Spinal Interlaminal Fixation Orthosis
Predicate Device Information
Sequoia Pedicle Screw System, K082032 (S.E. 10/7/2008) PathFinder Minimally Invasive Pedicle Screw System, K030625 (S.E.3/28/2003) Depuy Viper II, K090648 (S.E. 6/10/09)
Device Description and Technological Characteristics:
The purpose of this 510(k) submission is to modernize the existing PathFinder Pedicle Screw System. A set of percutaneous insertion rods and new instrumentation have been included for minimally invasive procedures.
The Zimmer Spine PathFinder II system consists of polyaxial cannulated screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine. A range of spinal rod lengths included in this system allows the surgeon to place polyaxial pedicle screws through an open or mini-open procedure. This system is intended only to provide stabilization during the development of a solid fusion with autograft or allograft. These implants are intended to be removed after the development of a solid fusion mass.
The predicate device, Sequoia Pedicle Screw System and the proposed PathFinder II device are fabricated from medical grade titanium alloy per ASTM F136 and commercially pure titanium per ASTM F67.
1
Intended Use / Indications for Use:
When intended for pedicle screw fixation from TI-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, 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 solid fusion is established.
Performance Data:
For a determination of substantial equivalence, the following non-clinical mechanical tests were performed:
Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717 were performed on the proposed PathFinder II system and predicate Sequoia Pedicle Screw system and the results compared. The proposed device functioned as intended and the observed test results demonstrate substantial equivalence to the aforementioned predicate device.
Substantial Equivalence:
The PathFinder II Minimally Invasive Pedicle Screw System has the same intended use and indications for use as the predicate Sequoia Pedicle Screw System. Additionally, no new issues of safety or effectiveness are raised. Based on the supporting documentation presented within this premarket notification, the proposed device is as safe and effective and performs as well as or better than the predicate device identified.
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 or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the central image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Zimmer Spine Inc. % Mr. David Padgett Senior Regulatory Affairs Specialist 5301 Riata Park Court, Building F Austin, Texas 78727
SEP 21 2010
Re: K100845
Trade/Device Name: PathFinder® II 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 09, 2010 Received: September 10, 2010
Dear Mr. Padgett:
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
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Page 2 - Mr. David Padgett
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark H. Milliken
Mark N. Melkerson 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
K100845 SEP 2 1 2010
510(k) Number (if known): K100845
Device Name: PathFinder® II 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 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 solid fusion is established.
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)
signature
(Division Sign-Off Division of Surgical, Orthopedic, and Kestorative Devices
KI00845 5 ! 0(k) Number_
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