(113 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which directly addresses a medical condition.
No
Explanation: The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions. It is a surgical implant designed to treat known conditions, not identify them.
No
The device description clearly states it is a "pedicle screw spinal fixation system" comprising "polyaxial screws, rigid rods and cross connectors," which are physical hardware components.
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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant used to stabilize the spine. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is to provide "immobilization and stabilization of spinal segments as an adjunct to fusion." This is a structural and mechanical function within the body, not an analysis of biological specimens.
The device is clearly a surgical implant and not an IVD.
N/A
Intended Use / Indications for Use
The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Exactech Proliant Polyaxial Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
This submission proposes a new pedicle screw spinal fixation system. The proposed Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rigid rods and cross connectors to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136). The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
The Proliant Polyaxial Pedicle Screw System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral 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 following mechanical testing and engineering analysis were conducted to demonstrate substantial equivalence of the proposed Proliant Polyaxial Pedicle Screw System to predicates Hydralok System and VSS/Extended VSS Systems:
- Static Compression Bending, Static Torsion, and Dynamic Compression Fatigue . testing per ASTM F1717.
- Biomechanical assessment comparing Proliant Polyaxial Pedicle Screw System . mechanical performance to cited predicate systems.
The results of mechanical testing and engineering analysis demonstrate the proposed devices are substantially equivalent to cited predicates.
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.
Not Found
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
§ 888.3070 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
Exactech® Proliant™ Polyaxial Pedicle Screw System Traditional 510(k)
510(k) Summary
| Company: | Exactech®. Inc
JAN 2 1 2011
2320 NW 66" Court
Gainesville, FL 32653 | |
|-------------------|----------------------------------------------------------------------------------------------------|--|
| Date: | November 22, 2010 | |
| Contact Person: | Vladislava Zaitseva
Regulatory Affairs Specialist
Phone: 508-377-1140
Fax: (352) 378-2617 | |
| Proprietary Name: | Exactech® Proliant™ Polyaxial Pedicle Screw System | |
| Common Name: | Pedicle screw spinal system | |
Classification Name:
21 CFR 888.3070 - Pedicle screw spinal system, Class II
- Product Code: MNI Orthosis, Spinal Pedicle Fixation .
- Product Code: MNH Orthosis, Spondylolisthesis Spinal Fixation .
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
Device Description
This submission proposes a new pedicle screw spinal fixation system. The proposed Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rigid rods and cross connectors to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136). The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
The Proliant Polyaxial Pedicle Screw System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.
1
K/02 8'70
Exactech® Proliant™ Polvaxial Pedicle Screw System Traditional 510(k)
Indications for Use
The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondy|olisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Exactech Proliant Polyaxial Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
Intended Use/Indications for Use. .
The Proliant Polyaxial Pedicle Screw System has the same indications for use and intended uses as the Hydralok System and similar indications for use and intended uses as VSS/Extended VSS Systems.
. Materials
The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems are composed of titanium, a biocompatible material conforming to a recognized industry standard for permanent implants.
. Design Features
The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems have similar design features.
. Dimensions
The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems are dimensionally comparable.
Packaging and Sterilization .
The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems are provided non-sterile for single use only. Both proposed and predicate systems will be steam sterilized by the hospital prior to use in the operating room using the same method.
Device Shelf Life ●
Neither the Proliant Polyaxial Pedicle Screw System nor identified predicates have shelf-life expiration dating.
2
Exactech® Proliant™ Polyaxial Pedicle Screw System Traditional 510(k)
. Performance specifications
The Proliant Polyaxial Pedicle Screw System and predicate systems withstand clinically relevant biomechanical loads.
Substantial Equivalence Conclusion
The following mechanical testing and engineering analysis were conducted to demonstrate substantial equivalence of the proposed Proliant Polyaxial Pedicle Screw System to predicates Hydralok System and VSS/Extended VSS Systems:
- Static Compression Bending, Static Torsion, and Dynamic Compression Fatigue . testing per ASTM F1717.
- Biomechanical assessment comparing Proliant Polyaxial Pedicle Screw System . mechanical performance to cited predicate systems.
The results of mechanical testing and engineering analysis demonstrate the proposed devices are substantially equivalent to cited predicates.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Exactech®, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 NW 66" Court Gainesville, Florida 32653
JAN 2 1 201
Re: K102870
Trade/Device Name: Exactech® Proliant™ Polyaxial Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: December 22, 2010 Received: December 23, 2010
Dear Ms. Zaitseva:
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
4
Page 2 - Ms. Vladislava Zaitseva
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 100-100.
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/ucm1178017; plcase the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Adonalization note the regulation entitled, "Misbranding by reference to premarket notfication" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (11 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 the (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 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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page 1 of 1
Exactech® Proliant™ Polyaxial Pedicle Screw System Traditional 510(k)
Indications for Use Statement
510(k) Number:
Device Name: Exactech® Proliant™ Polyaxial Pedicle Screw System
INDICATIONS FOR USE:
The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Proliant System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
Prescription Use __ X___ Over-The-Counter Use and/or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102870