(133 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated as an adjunct to fusion for various conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion, all of which are medical conditions that the device aims to treat or manage.
No
The device is described as a non-cervical spinal fixation device used as an adjunct to fusion for various spinal conditions, indicating it is a treatment device, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components like screws, rods, and locking caps, and the performance studies involve bench testing of these physical components.
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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "non-cervical spinal fixation device" intended for surgical implantation to stabilize the spine. It is used as an "adjunct to fusion" for various spinal conditions.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical support and stabilization within the body.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5:0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Product codes
NKB, MNH, MNI, KWQ, KWP
Device Description
This is an addition to Synthes' existing non-cervical spinal fixation devices intended for are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S2/ilium, T1-L5, T8-L5
Indicated Patient Age Range
Skeletally mature patients, small stature and pediatric 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)
Non-Clinical Performance and Conclusions: Bench testing results demonstrate that Synthes Matrix performs equivalently or superiorly to the above-mentioned predicates in static compression bending, static torsion, and dynamic compression bending (in accordance with ASTM F1717-11a).
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes USS, K963045, Synthes Click'X, K992739, Synthes Click'X, K031175, Synthes USS Illiosacral and Polyaxial, K082572, Synthes Matrix System, K092929, Synthes Matrix System, K093668, Synthes Matrix System, K100952, Synthes Matrix System, K100634
Reference Device(s)
Medtronic CD Horizon, K113529, EBI/Biomet Polaris, K111957, Aesculap S4, K112551, Synthes USS, K111358, Synthes MIRS, K113044, Synthes USS, K113149
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Name of Firm: | Synthes Spine | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| 510(k) | ||
| Contact: | Heather Guerin | |
| Senior Regulatory Affairs Specialist | ||
| Telephone: 610-719-5432 | ||
| Facsimile: 610-719-5102 | ||
| Email: guerin.heather@synthes.com | ||
| Date | ||
| Prepared: | June 28, 2012 | |
| Trade Name: | Synthes Matrix System | |
| Classification: | 21 CFR 888.3070 -Pedicle screw spinal system | |
| Class III | ||
| Orthopaedic and Rehabilitation Devices Panel | ||
| Product Code: NKB, MNH, MNI, KWQ, KWP | ||
| Predicates: | Synthes USS, K963045 | |
| Synthes Click'X, K992739 | ||
| Synthes Click'X, K031175 | ||
| Synthes USS Illiosacral and | ||
| Polyaxial, K082572 | ||
| Synthes Matrix System, K092929 | ||
| Synthes Matrix System, K093668 | ||
| Synthes Matrix System, K100952 | ||
| Synthes Matrix System, K100634 | Medtronic CD Horizon, K113529 | |
| EBI/Biomet Polaris, K111957 | ||
| Aesculap S4, K112551 | ||
| Synthes USS, K111358 | ||
| Synthes MIRS, K113044 | ||
| Synthes USS, K113149 | ||
| Device | ||
| Description: | This is an addition to Synthes' existing non-cervical spinal fixation devices intended for are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08). | |
| Intended Use/ | ||
| Indications for | ||
| Use: | The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by | |
| 510(k) Summary | ||
| history and radiographic studies), spondylolisthesis, trauma (i.e., | ||
| fracture or dislocation), deformities or curvatures (i.e., scoliosis, | ||
| kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, | ||
| and failed previous fusion (pseudoarthrosis). | ||
| When treating patients with Degenerative Disc Disease (DDD), | ||
| transverse bars are not cleared for use as part of the posterior | ||
| pedicle screw construct. | ||
| When used with the 3.5 mm/6.0mm parallel connectors, the Synthes | ||
| USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm | ||
| Systems. In addition, when used with 3.5 mm/5.0mm parallel | ||
| connectors, the Synthes Small Stature USS can be linked to the | ||
| CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm | ||
| parallel connectors, the Synthes Small Stature USS can be linked to | ||
| the Synthes USS 6.0 mm rod systems. When used with the 5.5 | ||
| mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm | ||
| rod systems can be linked to the Synthes USS 6.0 mm rod systems. | ||
| 5.5 mm/5.5mm parallel or extension connectors can be used to link | ||
| all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm | ||
| parallel or extension connectors can be used to link all Synthes USS | ||
| 6.0 mm rod systems to one another. | ||
| Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm | ||
| rod systems to one another. | ||
| When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered | ||
| rods, the Synthes USS 6.0 mm rod systems can be linked to the | ||
| CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with | ||
| the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS | ||
| 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 | ||
| mm Systems, respectively. When used with the 5.5 mm/6.0mm | ||
| tapered rods, the Synthes USS 6.0 mm rod systems can be linked to | ||
| Synthes USS 5.5 mm rod systems. | ||
| In addition, Synthes USS 6.0 mm rod systems can be interchanged | ||
| with all USS 6.0 mm rods and transconnectors except Synthes 6.0 | ||
| mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, | ||
| which can only be used with Pangea. Synthes USS 5.5 mm rod | ||
| systems can be interchanged with all USS 5.5 mm rods and | ||
| transconnectors. | ||
| Synthes USS | ||
| 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, | ||
| ● | ||
| USS VAS variable axis components. USS Fracture, Click'X | ||
| -510(k) Summary | Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, | |
| USS Iliosacral, ClampFix 5.5 mm Rod System: Matrix, MIRS 5.0 mm Rod System: USS Small Stature CerviFix 3.5 mm Rod Systems: CerviFix, Axon, Synapse 4.0 mm Rod System: Synapse | ||
| Comparison of | ||
| the device to | ||
| predicate | ||
| device(s): | Synthes Matrix is substantially equivalent to the above-mentioned | |
| predicates in design, function, material and intended use. | ||
| Performance | ||
| Data | ||
| (Non-Clinical | ||
| and/or | ||
| Clinical): | Non-Clinical Performance and Conclusions: | |
| Bench testing results demonstrate that Synthes Matrix performs | ||
| equivalently or superiorly to the above-mentioned predicates in static | ||
| compression bending, static torsion, and dynamic compression | ||
| bending (in accordance with ASTM F1717-11a). | ||
| Clinical Performance and Conclusions: | ||
| Clinical data and conclusions were not needed for this device. |
મૂં જ્
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Image /page/3/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 symbol, with its wings forming a curved shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Heather Guerin, Ph.D. Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K120838
Trade/Device Name: Synthes Matrix System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ, KWP Dated: June 28, 2012 Received: June 29, 2012
JUL 3 1 2012
Dear Dr. Guerin:
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 r lease oe action and a determination that your device complies with other requirements of the Act that 127 has intact a coulations administered by other Federal agencies. You must or uny rederal bakated and surveyed to the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Heather Guerin, Ph.D.
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 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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@ SYNTHES * Spine
Indications for Use Statement
510(k) Number: K120838 Synthes Matrix System Device Name:
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adiunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5:0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beethold formKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Synthes USS
- 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable o axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- 5.5 mm Rod System: Matrix, MIRS o
- 5.0 mm Rod System: USS Small Stature ' o
CerviFix
- 3.5 mm Rod Systems: CerviFix, Axon, Synapse o
- 4.0 mm Rod System: Synapse o
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seelhold for MXM
(Division Sign-Off)
Division at surgical. Orthopedic, and Restorative Devices
510(k) Number K120838