(118 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a spinal fixation device, which is implanted to provide stability and support to the spine, and is used as an adjunct to fusion for various medical conditions like degenerative disc disease, trauma, and deformities. These functions are inherently therapeutic as they aim to treat or alleviate a disease or injury.
No
The device is described as a non-cervical spinal fixation device, intended for surgical procedures to stabilize parts of the spine. It is a treatment device, not a device used to diagnose a medical condition.
No
The device description clearly states that the device consists of implants made from various materials like titanium and cobalt-chromium-molybdenum alloy, which are physical hardware 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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Synthes USS and Matrix Systems are "non-cervical spinal fixation devices" and describes their components as implants like screws, rods, and hooks. These are physical devices implanted into the body.
- Intended Use: The intended use is for "posterior pedicle screw fixation," "posterior hook fixation," or "anterolateral fixation" as an "adjunct to fusion" for various spinal conditions. This involves surgically implanting devices to stabilize the spine.
The device is a surgical implant used for spinal fixation, not a device used to test samples outside of the body.
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, 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 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.
When used with the 3.5/6.0 mm and 4.0/6.0 mm 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 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be lined to the Matrix System.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 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, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- 5.5 mm Rod System: Matrix
- 5.0 mm Rod System: USS Small Stature
CerviFix
- 3.5 mm Rod Systems: CerviFix, Axon, Synapse
- 4.0 mm Rod System: Synapse
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWQ, KWP
Device Description
The Synthes Matrix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The Matrix System consists of a family of non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5) or anterolateral fixation (T8-L5). The implants include pedicle bone screws, polyaxial pedicle screws, monoaxial pedicle screws, polyaxial heads, reduction screws, reduction heads, locking caps, transconnectors, transverse bars, rods and hooks. The implants are primarily manufactured from titanium (ASTM F67 - 06), titanium alloy (ASTM F1295 - 05), cobalt-chromium-molybdenum alloy (ASTM F1537 - 08) or nitinol (ASTM F2063 - 05), similar to the predicates.
The subject of this submission is the addition of transverse bars and tapered rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5)
Indicated Patient Age Range
skeletally mature patients with the exception of the Small Stature USS, which includes 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)
Synthes conducted the following non-clinical testing: static compression bend, static torsion, and dynamic compression bend testing in accordance with ASTM F1717–09. The conclusions drawn from testing demonstrate that the Matrix System is as safe and effective and performs as well as or better than the predicate devices identified. Clinical data was not needed for this device.
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.
Synthes Univeral Sacral System, K963045, Synthes Matrix System, K092929, Synthes Pangea System, K052151, Synthes Click'X Monoaxial, K031175, Synthes Dual Opening USS, K023675, Synthes USS, K022949, Synthes USS Iliosacral and USS Polyaxial, K082572, Synthes CerviFix, K001864, Synthes Synapse System, K070573
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
K10a34 Page 1 of 2
SYNTHES®
Spine
4 510(k) Summary
JUL -1 2010
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Amnon Talmor |
| Spine Regulatory Affairs Specialist | |
| Telephone: 610-719-5446 | |
| Facsimile: 610-719-5102 | |
| Email: talmora@synthes.com | |
| Date Prepared: | March 3, 2010 |
| Trade Name: | Synthes Matrix System |
| Classification: | 21 CFR 888.3050-Spinal interlaminar fixation orthosis |
| 21 CFR 888.3060-Spinal intervertebral body fixation orthosis | |
| 21 CFR 888.3070-Pedicle screw spinal system | |
| Class III | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code: NKB, MNH, MNI, KWQ, KWP | |
| Predicate Devices: | Synthes Univeral Sacral System, K963045 |
| Synthes Matrix System, K092929 | |
| Synthes Pangea System, K052151 | |
| Synthes Click'X Monoaxial, K031175 | |
| Synthes Dual Opening USS, K023675 | |
| Synthes USS, K022949 | |
| Synthes USS Iliosacral and USS Polyaxial, K082572 | |
| Synthes CerviFix, K001864 | |
| Synthes Synapse System, K070573 | |
| Device | The Synthes Matrix System is an addition to Synthes' existing posterior |
| Description: | thoracolumbar spine systems. The Matrix System consists of a family of non- |
| cervical spinal fixation devices intended for posterior pedicle screw fixation | |
| (T1-S2), posterior hook fixation (T1-L5) or anterolateral fixation (T8-L5). The | |
| implants include pedicle bone screws, polyaxial pedicle screws, monoaxial | |
| pedicle screws, polyaxial heads, reduction screws, reduction heads, locking | |
| caps, transconnectors, transverse bars, rods and hooks. The implants are | |
| primarily manufactured from titanium (ASTM F67 - 06), titanium alloy | |
| (ASTM F1295 - 05), cobalt-chromium-molybdenum alloy (ASTM F1537 | |
| - 08) or nitinol (ASTM F2063 - 05), similar to the predicates. | |
| The subject of this submission is the addition of transverse bars and | |
| tapered rods. | |
| Intended Use/ | The Synthes USS are non-cervical spinal fixation devices intended for |
| Indications for | posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1- |
| Use: | 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 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm | |
| rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when | |
| used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can | |
| be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm | |
| parallel connectors, the Synthes Small Stature USS can be linked to the | |
| Synthes USS 6.0 mm rod systems. | |
| When used with the 3.5/6.0 mm and 4.0/6.0 mm 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 3.5/5.5 mm and 4.0/5.5 mm | |
| tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm | |
| Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the | |
| Synthes USS 6.0 mm rod systems can be linked to the Matrix System. | |
| In addition, Synthes USS 6.0 mm rod systems can be interchanged with all | |
| USS 6.0 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, Click'X Monoaxial, | |
| Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix 5.5 mm Rod System: Matrix 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 | |
| technological | |
| characteristics of | |
| the device to the | |
| predicate device: | The design features, material, and indications for use of the subject Matrix |
| System is substantially equivalent to the predicate devices identified. | |
| Additionally, the safety and effectiveness of this system is adequately | |
| supported by documentation within this premarket notification. | |
| Performance Data | |
| (Non-Clinical | |
| and/or Clinical): | Synthes conducted the following non-clinical testing: static compression |
| bend, static torsion, and dynamic compression bend testing in accordance | |
| with ASTM F1717–09. The conclusions drawn from testing demonstrate | |
| that the Matrix System is as safe and effective and performs as well as or | |
| better than the predicate devices identified. Clinical data was not needed for | |
| this device. |
1
K100634 Page 2 of 2
:
@ SYNTHES® Spine
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The text is in uppercase letters and is positioned around the upper half of the circular logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL -1 2010
Synthes Spine % Mr. Amon Talmor Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K100634
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, MNI, MNH, KWP, KWQ Dated: June 25, 2010 Received: June 28, 2010
Dear Mr. Talmor:
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
3
Page 2 - Mr. Amon Talmor
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 (OS) 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.
Barbara Hughum
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
page 1 of 1
@ SYNTHES® Spine
4 Indications for Use Statement
510(k) Number: K100634 Device Name: Synthes Matrix System
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, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, 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 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.
When used with the 3.5/6.0 mm and 4.0/6.0 mm 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 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be lined to the Matrix System.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.
Synthes USS
- 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, o USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- 5.5 mm Rod System: Matrix O
- o 5.0 mm Rod System: USS Small Stature
CerviFix
- 3.5 mm Rod Systems: CerviFix, Axon, Synapse O
- 4.0 mm Rod System: Synapse O
Prescription Use × (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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
ad Restorative Devices
thes Matrix System K106680(k) Number
Synthes Matrix System K10@600(K) Number