(69 days)
Not Found
No
The device description and intended use focus on a mechanical power adaptor for screw insertion, with no mention of AI or ML capabilities.
No
This device is an instrument (power adaptor) used to facilitate the placement of pedicle screws, not a therapeutic device itself. The therapeutic aspect comes from the implanted pedicle screws and the overall spinal fusion procedure, not this specific tool.
No
Explanation: The device is described as a power adaptor instrument accessory intended to facilitate the insertion of pedicle screws for surgical procedures, not for diagnosis.
No
The device description explicitly states it is a "power adaptor instrument accessory" and describes it as a "mechanical interface" between a power driver and a screwdriver instrument. This indicates a physical hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "instrument accessory" intended to "facilitate the insertion of pedicle screws using powered instrumentation" during spinal surgery. It's a tool used on the patient during a surgical procedure, not for analyzing samples from the patient.
- Intended Use: The intended use is for surgical procedures involving the spine, specifically the placement of pedicle screws. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical instrument accessory, not an IVD.
N/A
Intended Use / Indications for Use
To facilitate the placement of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. When the adaptors are attached, the RemB Corded Driver provides power to rotate screw drivers for inserting of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature noncervical spine using powered instrumentation. The systems include the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal Systems.
The Xia® Spinal System is intended for anterior/anteral and posterior, noncervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion.
The XIA® 4.5, XIA® 3, Radius® Spinal Systems are intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fusion using autograft or allograff in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal Stenosis; Curvatures (i.e., scoliosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion.
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, and/or lordosis); tumor; Pseudoarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
The line extension, which is the subject of this 510(k), consists of the addition of a power adaptor instrument accessory. This adaptor instrument is intended to facilitate the insertion of pedicle screws using powered instrumentation. This 510(k) supports a labeling update to include the option for pedicle screw insertion using powered instrumentation (in addition to the existing manual insertion technique). To facilitate the insertion of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. The adaptors serve as a mechanical interface between the power driver and screwdriver instrument. When the adaptors are attached, the RemB Corded Driver provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems: Xia Spinal System (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal System. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, thoracolumbar spinal system
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)
A Risk assessment was conducted and identified the appropriate testing plan. Bench testing activities consisted of fatigue and functional compatibility testing performed with the power adaptor instrument over a simulated usage period. The Testing results demonstrated that the subject instrument can withstand screw loading and screw insertion during normal use without loss of function. Bench testing results also demonstrated that the power adaptor instrument is compatible with existing screwdriver instruments. To further evaluate the safety of the power pedicle screw insertion technique using the instrumentation mentioned herein, the power adaptor and associated instrumentation were tested under simulated use conditions to evaluate the quality/accuracy of screw placement.
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.
K060361, K091291, K092605, K101144, K102235, K101168
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
Line Extension to Stryker Spine Thoracolumbar Spinal System Inclusion of Power Adaptor Instrument Accessory
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Line Extension to Stryker Spine Spinal Systems: Xia, Xia 3, Xia 4.5, Radius, Mantis and Mantis Redux Systems Power Adaptor Instrument Accessory Proprietary Name: Common Name: Spinal Fixation Appliances, Instrument Accessory Pedicle Screw Spinal System, 21 CFR §888.3070 (b) (1) & (b) (2) Classification Name and Reference: Device Product Code: NKB, MNH, MNI Proposed Regulatory Class: Class III For Information contact: Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8296 Fax: (201) 760-8496 Email: Curtis. Truesdale(@Stryker.com Date Summary Prepared: August 3, 2011 Predicate Devices . Stryker Spine XIA Spinal Systems, K060361; ■ Stryker Spine XIA 3 Spinal System, K091291; 해 Stryker Spine XIA 4.5 Spinal System, K092605; 트 Stryker Spine RADIUS Spinal System, K 101 144; . Stryker Spine MANTIS Spinal System, K 102235; 트 Medtronic LEGEND Power Adaptor, K 101168;
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Line Extension to Stryker Spine Thoracolumbar Spinal System Inclusion of Power Adaptor Instrument Accessory
Special 510(k) Premarket Notification
Description of Device Modification
The line extension, which is the subject of this 510(k), consists of the addition of a power adaptor instrument accessory. This adaptor instrument is intended to facilitate the insertion of pedicle screws using powered instrumentation. This 510(k) supports a labeling update to include the option for pedicle screw insertion using powered instrumentation (in addition to the existing manual insertion technique). To facilitate the insertion of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. The adaptors serve as a mechanical interface between the power driver and screwdriver instrument. When the adaptors are attached, the RemB Corded Driver provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems: Xia Spinal System (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal System. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.
Intended Use and Indications for Use
To facilitate the placement of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. When the adaptors are attached, the RemB Corded Driver provides power to rotate screw drivers for inserting of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature noncervical spine using powered instrumentation. The systems include the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal Systems.
The Xia® Spinal System is intended for anterior/anteral and posterior, noncervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion.
Page 2 of 3
2
Line Extension to Stryker Spine Thoracolumbar Spinal System Inclusion of Power Adaptor Instrument Accessory
Special 510(k) Premarket Notification
The XIA® 4.5, XIA® 3, Radius® Spinal Systems are intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fusion using autograft or allograff in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal Stenosis; Curvatures (i.e., scoliosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion.
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, and/or lordosis); tumor; Pseudoarthrosis; and failed previous fusion.
Summary of the Technological Characteristics
A Risk assessment was conducted and identified the appropriate testing plan. Bench testing activities consisted of fatigue and functional compatibility testing performed with the power adaptor instrument over a simulated usage period. The Testing results demonstrated that the subject instrument can withstand screw loading and screw insertion during normal use without loss of function. Bench testing results also demonstrated that the power adaptor instrument is compatible with existing screwdriver instruments. To further evaluate the safety of the power pedicle screw insertion technique using the instrumentation mentioned herein, the power adaptor and associated instrumentation were tested under simulated use conditions to evaluate the quality/accuracy of screw placement. The Stryker Spine Adaptor has similar technological characteristics as the previously 510(k) cleared Medtronic LEGEND Power Adaptor.
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3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG - 4 2011
Stryker Corporation % Ms. Tiffani Rogers 2 Pearl Court Allendale, New Jersey 07401
Re: K111478
Trade/Device Name: Stryker Spine Power Adaptor Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: July 01, 2011 Received: July 06, 2011
Dear Ms. Rogers:
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
4
Page 2 - Ms. Tiffani Rogers
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Line Extension to Stryker Spine Thoracolumbar Spinal Systems Inclusion of Power Adaptor Instrument Accessory
Special 510(k) Premarket Notification (Bundle)
Indications for Use
510(k) Number (if known): KJ11478
Device Name: Stryker Spine Power Adaptor Instrument
Intended Use:
To facilitate the placement of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. When the adaptors are attached, the RemB Corded Driver provides power to rotate screw drivers for inserting of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered instrumentation. The systems include the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal Systems.
Indications for Use:
The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 4.5. XIA® 3. Radius® Spinal Systems are intended for use in the noncervical spine. When used as an anterior/anteral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal Stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion.
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; Pseudoarthrosis; and failed previous fusion.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (21 CFR 801 Subpart D) | (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) | |||
| Jonathon L. for MXM 8/3/11 |
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111478
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