(78 days)
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
- Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fracture of dislocation)
- Spinal Stenosis
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- Failed Previous Fusion
The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Intended Use (Power Adaptor Instrument Accessory):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are 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, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.
Indications for Use (Power Adaptor Instrument Accessory):
The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion 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; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/ anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS® Spinal Systems are 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 XIA® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.
The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The MANTIS® Spinal System, MANTIS® Redux Spinal System, and ES2® 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.
-
The XIA® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, growth connectors, and cross connectors to vertebrae of the spinal column. This submission will introduce new cannulated and non-cannulated polyaxial screws, dual lead self-tapping cortical thread screws, a blocker, top loading rod-to-rod connectors, angled side/top loading connectors, and transition rods. The new XIA® 4.5 components consist of additional polyaxial diameter screws (Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø 6.5, Ø8.5 and Ø9.5) in cannulated and non-cannulated designs in various lengths (20mm – 100mm), a blocker, and a new transition rod. The new components will be used in the same manner as the existing predicate XIA® 4.5 Spinal System.
-
The XIA® 4.5 Spinal System will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument, Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, to facilitate the insertion of the pedicle screws. The adaptors serve as a mechanical interface between the power drivers and screwdriver instruments. When the adaptor is attached to the Hudson Modified Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 provides appropriate power to rotate the screw drivers for the insertion of the pedicle screws. The accessory indications for use were updated to reflect the indications for use of the XIA® 4.5 Spinal System.
This is a 510(k) premarket notification for the Stryker Corporation's XIA® 4.5 Spinal Fixation System and its Power Adaptor Instrument Accessory. The document describes the devices and asserts their substantial equivalence to predicate devices based on non-clinical testing. It does not involve a study of artificial intelligence (AI) performance in a clinical setting; therefore, many of the requested criteria cannot be extracted from this document.
Here's what can be extracted:
-
A table of acceptance criteria and the reported device performance
The document primarily describes non-clinical performance testing to demonstrate substantial equivalence, rather than clinical acceptance criteria in the context of AI performance. The "acceptance criteria" here are implicitly meeting the standards and performance of the predicate devices.
Acceptance Criteria (Implicit) Reported Device Performance Compliance with FDA's Guidance for Spinal System 510(k) Engineering analysis and applicable ASTM testing completed. Mechanical Performance (various ASTM standards) Mechanical and characterization tests performed:1. Static Compression (per ASTM F1717-14)Static Torsion (per ASTM F1717-14)Dynamic Compression Bending (ASTM F1717-14)Axial Pull Out Strength (per ASTM F2193-14 / ASTM F543-13)Flexion - Extension (per ASTM F1798-13)Axial Gripping (per ASTM F1798-13)Axial Torque Gripping (per ASTM F1798-13)Axis Tightening Torque2. Power Screw Insertion - Cadaveric Validation Study Substantial Equivalence to Predicate Devices (XIA® 4.5 system) Demonstrated substantial equivalence to identified predicate devices (K142381, K140276, K133188, K121342, K060361, K020709, K950697, K101144). Substantial Equivalence to Predicate Devices (Power Adaptor) Demonstrated substantial equivalence to identified predicate device (K120434). Same materials, geometries, and fundamental scientific technologies as predicate device The subject XIA® 4.5 Spinal System shares the same materials, geometries, and fundamental scientific technologies as the predicate XIA® 4.5 Spinal System. No changes to existing power adaptor accessory instruments No changes were made to the existing power adaptor accessory instruments to accommodate the subject device. -
Sample size used for the test set and the data provenance
The document mentions "Power Screw Insertion - Cadaveric Validation Study" but does not specify the sample size or provenance for this non-clinical test.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a mechanical spinal fixation system and an accessory, not an AI device that requires expert-established ground truth.
-
Adjudication method for the test set
Not applicable. This is a submission for a mechanical spinal fixation system and an accessory, not an AI device that requires adjudication of findings.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a mechanical spinal fixation system and an accessory, not an AI device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a submission for a mechanical spinal fixation system and an accessory, not an AI device.
-
The type of ground truth used
For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established by ASTM standards and the performance of the predicate devices. For the cadaveric study, the "ground truth" would be the successful physical insertion of screws in cadaveric models.
-
The sample size for the training set
Not applicable. This is a submission for a mechanical spinal fixation system and an accessory, not an AI device that involves a training set.
-
How the ground truth for the training set was established
Not applicable. This is a submission for a mechanical spinal fixation system and an accessory, not an AI device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human face in profile, with three overlapping faces suggesting community and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2015
Stryker Corporation Ms. Sorava King Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K152632 Trade/Device Name: XIA® 4.5 Spinal Fixation System, Power Adaptor Instrument Accessory Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: September 14, 2015 Received: September 16, 2015
Dear Ms. King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|---|
| Expiration Date: January 31, 2017 | Food and Drug Administration |
| See PRA Statement below. | Indications for Use |
| 510(k) Number (if known) | K152632 |
|---|---|
| Device Name | XIA® 4.5 Spinal Fixation System |
| Indications for Use (Describe) |
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle
fixation for the following indications:
- Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by
patient history and radiographic studies) - Spondylolisthesis
- Trauma (i.e. fracture of dislocation)
- Spinal Stenosis
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- Failed Previous Fusion
The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the
XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature
patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5
Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the
XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture
caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with
autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K152632 |
|---|---|
| Device Name | Power Adaptor Instrument Accessory |
| Indications for Use (Describe) |
|---|
| Intended Use (Power): |
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker
Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the
Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power
adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to
rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered
(corded and cordless) instrumentation. The systems included are 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, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.
| Indications for Use (Power): |
|---|
| ------------------------------ |
The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle
fixation in skeletally mature patients as an adjunct to fusion 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; curvature (i.e. scoliosis, kyphosis, and/or
lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/
anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS®
Spinal Systems are 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 XIA® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle
fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of
dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; failed previous
fusion.
The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System, and XIA® 4.5 Spinal System can be linked to
the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally
mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5
Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the
XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture
caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with
| FORM FDA 3881 (8/14) | Page 1 of 2 |
|---|---|
| PSC Publishing Services (301) 443-6740 | EF |
{4}------------------------------------------------
antografi and/or allogues. Pediatic person fixation is limited to a posterior sproach
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CONTINUE ON A SEPARATE PAGE IF NEEDED.
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{5}------------------------------------------------
| XIA® 4.5 Spinal Fixation System | |
|---|---|
| Submitter | Stryker Corporation2 Pearl CourtAllendale, New Jersey 07401 |
| Contact Person | Soraya KingRegulatory Affairs Project ManagerPhone: 201-749-8296Email: Soraya.King@stryker.com |
| Date | November 23, 2015 |
| Trade Name | 1. XIA® 4.5 Spinal Fixation System2. Power Adaptor Instrument Accessory |
| Proposed Class | Class III |
| Classification Nameand Number | Pedicle Screw Spinal System, 21 CFR 888.3070 |
| Product Code | NKB, OSH, MNH, MNI, KWP, KWQ |
| Predicate Devices | 1. The XIA® 4.5 Spinal Fixation Systems was shown to besubstantially equivalent to the devices listed below:PrimaryPredicateStryker Spine XIA® 4.5 Spinal System, K142381 AdditionalPredicates Stryker Spine XIA® 4.5 Spinal System (K140276, K133188, K121342, K060361) Medtronic CD Legacy (Horizon), K020709 DePuy Motech Moss Miami, K950697 Stryker Spine RADIUS® Spinal System, K101144 Stryker Spine XIA® 3 Spinal System, K142381 |
| 2. The Stryker Spine Power Adaptor Instrument Accessorywas shown to be substantially equivalent to the device listedbelow:Additional Predicate Stryker Spine Power Adaptor Instrument Accessory, K120434 | |
| Device Description | 1. The XIA® 4.5 Spinal System is comprised of monoaxial andpolyaxial bone and reduction screws, hooks, dual staples, andblockers that affix rods, rod-to-rod connectors, growthconnectors, and cross connectors to vertebrae of the spinalcolumn. This submission will introduce new cannulated and |
| XIA® 4.5 Spinal Fixation System | |
| non-cannulated polyaxial screws, dual lead self-tappingcortical thread screws, a blocker, top loading rod-to-rodconnectors, angled side/top loading connectors, andtransition rods. | |
| The new XIA® 4.5 components consist of additional polyaxialdiameter screws (Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø 6.5, Ø8.5 andØ9.5) in cannulated and non-cannulated designs in variouslengths (20mm – 100mm), a blocker, and a new transition rod.The newcomponents will be used in the same manner as theexisting predicate XIA® 4.5 Spinal System. | |
| 2. The XIA® 4.5 Spinal System will continue to be usedwith the Stryker Spine Power Adaptor AccessoryInstrument, Stryker Instruments Hudson Modified TrinkleReamer, the CD3 Cordless Driver 3 System, and the RemBUniversal Driver, to facilitate the insertion of the pediclescrews. The adaptors serve as a mechanical interfacebetween the power drivers and screwdriver instruments.When the adaptor is attached to the Hudson ModifiedTrinkle Reamer, the RemB Corded driver or the CD3Cordless Driver 3 provides appropriate power to rotate thescrew drivers for the insertion of the pedicle screws. Theaccessory indications for use were updated to reflect theindications for use of the XIA® 4.5 Spinal System. | |
| Intended Use andIndications for Usefor the XIA® 4.5Spinal System | |
| The XIA® 4.5 Spinal System is intended foranterior/anteriolateral and posterior, non-cervical pedicle andnon-pedicle fixation for the following indications: | |
| Degenerative Disc Disease (as defined by back pain ofdiscogenic origin with degeneration of the disc confirmedby patient history and radiographic studies) | |
| • Spondylolisthesis | |
| • Trauma (i.e. fracture of dislocation) | |
| • Spinal Stenosis | |
| • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) | |
| • Tumor | |
| • Pseudarthrosis | |
| • Failed Previous Fusion | |
| The Stryker Spine DIAPASON® Spinal System, Opus® SpinalSystem, and XIA® 4.5 Spinal System can be linked to the XIA®4.5 Spinal System via the rod-to-rod connector when used forthe aforementioned indications in skeletally mature patients asan adjunct to fusion. | |
| XIA® 4.5 Spinal Fixation System | |
| Except for the staples, when used for posterior non-cervicalpedicle screw fixation in pediatric patients, the XIA® 4.5 SpinalSystem implants are indicated as an adjunct to fusion to treatprogressive spinal deformities (i.e. scoliosis, kyphosis, orlordosis) including idiopathic scoliosis, neuromuscularscoliosis, and congenital scoliosis. Additionally, the XIA® 4.5Spinal System is intended to treat pediatric patients diagnosedwith: spondylolisthesis/spondylolysis, fracture caused by tumorand/or trauma, pseudarthrosis, and/or failed previous fusion.This system is intended to be used with autograft and/orallograft. Pediatric pedicle screw fixation is limited to aposterior approach. | |
| Indications &Intended Use withPower AdaptorInstrumentAccessory | Intended Use:To facilitate the placement of pedicle screws using the powertechnique (corded and cordless), the use of the Stryker SpinePower Adaptor is intended for exclusive use with the StrykerInstruments Hudson Modified Trinkle Reamer and the StrykerInstruments CD3 Cordless Driver 3 and the StrykerInstruments RemB Universal Driver. When the poweradaptors are attached, the CD3 Cordless Driver 3 and RemBUniversal Driver provide power (corded and cordless) to rotatescrewdrivers for the insertion of pedicle screws.Pedicle screws from select Stryker Spine implant systemsmay be implanted in the non-cervical spine using powered(corded and cordless) instrumentation. The systems includedare the family of XIA® Spinal Systems (XIA® Stainless Steel,XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 SpinalSystem, XIA® 4.5 Spinal System, Radius® Spinal System,MANTIS® Spinal System, MANTIS® Redux Spinal System,and the ES2® Spinal System. |
| Indications for Use:The XIA® Spinal System is intended foranterior/anteriolateral and posterior, non-cervical pedicleand non-pedicle fixation in skeletally mature patients as anadjunct to fusion for the following indications: DegenerativeDisc disease (DDD) (defined as back pain of discogenicorigin with degeneration of the disc confirmed by historyand radiographic studies); spondylolisthesis; trauma (i.e.fracture or dislocation); spinal stenosis; curvature (i.e.scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis;and failed previous fusion. | |
| XIA® 4.5 Spinal Fixation System | |
| The XIA® 3, RADIUS® Spinal Systems are intended for use inthe non-cervical spine. When used as ananterior/anteriolateral and posterior, non-cervical pedicle andnon-pedicle fixation system, the XIA® II, XIA® 3, andRADIUS® Spinal Systems are intended to provide additionalsupport during fusion using autograft or allograft in skeletallymature patients in the treatment of the following acute andchronic instabilities or deformities: degenerative disc disease(DDD) (defined as back pain of discogenic origin withdegeneration of the disc confirmed by history andradiographic studies); spondylolisthesis; trauma (i.e. fractureor dislocation); spinal stenosis; curvatures (i.e. scoliosis,kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failedprevious fusion. | |
| The XIA® 4.5 Spinal System is intended foranterior/anterolateral and posterior, non-cervical pedicle andnon-pedicle fixation for the following indications:degenerative disc disease (as defined by back pain ofdiscogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies); spondylolisthesis;trauma (i.e. fracture of dislocation); spinal stenosis;curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor;pseudarthrosis; failed previous fusion. | |
| The Stryker Spine DIAPASON® Spinal System, OPUS® SpinalSystem, and XIA® 4.5 Spinal System can be linked to theXIA® 4.5 Spinal System via the rod-to-rod connector when usedfor the aforementioned indications in skeletally mature patientsas an adjunct to fusion. | |
| Except for the staples, when used for posterior non-cervicalpedicle screw fixation in pediatric patients, the XIA® 4.5Spinal System implants are indicated as an adjunct to fusion totreat progressive spinal deformities (i.e. scoliosis, kyphosis, orlordosis) including idiopathic scoliosis, neuromuscularscoliosis, and congenital scoliosis. Additionally, the XIA® 4.5Spinal System is intended to treat pediatric patients diagnosedwith: spondylolisthesis/spondylolysis, fracture caused bytumor and/or trauma, pseudarthrosis, and/or failed previousfusion. This system is intended to be used with autograftand/or allograft. Pediatric pedicle screw fixation is limited to aposterior approach. | |
| XIA® 4.5 Spinal Fixation System | |
| The MANTIS® Spinal System, MANTIS® Redux SpinalSystem, and ES2® Spinal System is intended for percutaneous,posterior, non-cervical pedicle and non-pedicle fixation of thespine to provide immobilization and stabilization of spinalsegments in skeletally mature patients as an adjunct to fusionfor the following indications: degenerative disc disease(defined as back pain of discogenic origin with degeneration ofthe disc confirmed by history and radiographic studies);spondylolisthesis; trauma (i.e. fracture or dislocation); spinalstenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis);tumor; pseudoarthrosis; and failed previous fusion. | |
| Summary of theTechnologicalCharacteristics | 1. The subject XIA® 4.5 Spinal System shares the samematerials, geometries, and fundamental scientific technologiesas the predicate XIA® 4.5 Spinal System. |
| 2. The XIA® 4.5 bone screws are also intended to be insertedmanually or under power (cordless and corded) utilizing theCD3 Cordless Driver 3 or the RemB Universal Driver handheld devices. Both drivers connect to the screwdriver via theHudson Modified Trinkle Reamer which mates to the StrykerSpine Power Adaptor. The power adaptor accessory instrumentassembly aids in the rotation of the bone screw to facilitateinsertion. No changes were made to the existing power adaptoraccessory instruments to accommodate the subject device. | |
| Summary ofNon-Clinical Testing/ Performance Data | The Stryker Spine XIA® 4.5 Spinal Systems, with theincorporation of the subject components, has demonstratedsubstantial equivalence to the predicate device. Engineeringanalysis and applicable ASTM testing to demonstratecompliance with FDA's Guidance for Spinal System 510(k)May 3, 2004 were completed for the systems. The followingmechanical and characterization tests were performed: |
| 1.Static Compression (per ASTM F1717-14) Static Torsion (per ASTM F1717-14) Dynamic Compression Bending (ASTM F1717-14) Axial Pull Out Strength (per ASTM F2193-14 / ASTM F543-13) Flexion - Extension (per ASTM F1798-13) Axial Gripping (per ASTM F1798-13) Axial Torque Gripping (per ASTM F1798-13) Axis Tightening Torque 2.Power Screw Insertion - Cadaveric Validation Study | |
| XIA® 4.5 Spinal Fixation System | |
| Conclusion | Based on the design features, the use of established well-known materials, feature comparisons, indications for use, and results of the mechanical and characterization testing, the subject devices have demonstrated substantial equivalence to the identified predicate devices. |
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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.