(65 days)
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 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods. Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm 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.
The Synthes CoCr and Cp Ti-3 Rods are an addition to Synthes' existing posterior thoracolumbar spine systems. These are 6.0mm diameter rods that will be used with Synthes Pangea polyaxial screws and locking caps.
The rods are comprised of commercially pure titanium grade 3 (Cp Ti-3) and Cobalt Chrome Molybdenum (Co-28CR-6Mo) ASTM F67 and ASTM F1537, the same as the predicate device.
The provided document describes the Synthes Pangea System, which includes CoCr and Cp Ti-3 Rods. The study conducted to prove the device meets acceptance criteria is a non-clinical performance test.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|
| Static compression bend in accordance with ASTM F1717 - 04/09 | The conclusions drawn from testing demonstrate that the CoCr and Cp Ti-3 Rods are substantially equivalent to the predicate devices identified. (Specific numerical data or thresholds are not provided in this summary.) |
| Static torsion in accordance with ASTM F1717 - 04/09 | The conclusions drawn from testing demonstrate that the CoCr and Cp Ti-3 Rods are substantially equivalent to the predicate devices identified. (Specific numerical data or thresholds are not provided in this summary.) |
| Dynamic compression bend in accordance with ASTM F1717 - 04/09 | The conclusions drawn from testing demonstrate that the CoCr and Cp Ti-3 Rods are substantially equivalent to the predicate devices identified. (Specific numerical data or thresholds are not provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. The document states "Synthes conducted the following non-clinical testing," but does not mention the number of rods or test articles used.
- Data Provenance: The study was a non-clinical (laboratory) test. Therefore, there is no patient data or geographical origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The "ground truth" for this device's acceptance was established through non-clinical mechanical testing based on ASTM standards, not through expert review of clinical cases.
4. Adjudication method for the test set
This information is not applicable to this submission as the "test set" involved mechanical laboratory testing, not human interpretation or adjudication of clinical data.
5. 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
An MRMC comparative effectiveness study was not done. This device is a spinal implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for device performance was established through mechanical testing standards (ASTM F1717 - 04/09). The performance of the rods (static compression bend, static torsion, dynamic compression bend) was measured against the requirements of this standard to demonstrate substantial equivalence to predicate devices.
8. The sample size for the training set
This information is not applicable. This device is a physical medical implant and does not involve a "training set" in the context of machine learning or algorithms. The testing described is verification and validation testing for a manufactured product.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no "training set" for this type of device.
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K103287
SYNTHES
Spine
:
JAN - 5 2011
Spine
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| 510(k) Contact: | Elizabeth KierzekAssociate Regulatory Affairs SpecialistPhone: 610-719-5722Fax: 610-719-5102Email: Kierzek.Elizabeth@synthes.com |
| Date Prepared: | December 9, 2010 |
| Trade Name: | Synthes Pangea System |
| Classification: | Orthopaedic and Rehabilitation Devices PanelClass III |
| 21 CFR 888.3070 - Pedicle screw spinal systemProduct Code: NKB, MNH, MNI | |
| 21 CFR 888.3060 - Spinal intervertebral body fixation orthosisProduct Code: KWQ | |
| 21 CFR 888.3050 - Spinal interlaminal fixation orthosisProduct Code: KWP | |
| Predicate Devices: | |
| DeviceDescription: | The Synthes CoCr and Cp Ti-3 Rods are an addition to Synthes'existing posterior thoracolumbar spine systems. These are 6.0mmdiameter rods that will be used with Synthes Pangea polyaxialscrews and locking caps. |
| The rods are comprised of commercially pure titanium grade 3(Cp Ti-3) and Cobalt Chrome Molybdenum (Co-28CR-6Mo)ASTM F67 and ASTM F1537, the same as the predicate device. | |
| Intended Use /Indications forUse: | The Synthes USS are non-cervical spinal fixation devices intendedfor posterior pedicle screw fixation (T1-S2/ilium), posterior hookfixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screwfixation is limited to skeletally mature patients with the exceptionof the Small Stature USS, which includes small stature andpediatric patients. These devices are indicated as an adjunct tofusion for all of the following indications: degenerative discdisease (defined as discogenic back pain with degeneration of thedisc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fracture or dislocation), deformitiesor curvatures (i.e., scoliosis, kyphosis, and/or lordosis,Scheuermann's Disease), tumor, stenosis, and failed previousfusion (pseudoarthrosis).When treating patients with Degenerative Disc Disease (DDD),transverse bars are not cleared for use as part of the posteriorpedicle screw construct.When used with the 3.5/6.0mm parallel connectors, the SynthesUSS 6.0mm rod systems can be linked to the CerviFix 3.5mmSystems. In addition, when used with 3.5/5.0mm parallelconnectors, the Synthes Small Stature USS can be linked to theCerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallelconnectors, the Synthes Small Stature USS can be linked to theSynthes USS 6.0mm rod systems.When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, theSynthes USS 6.0mm rod systems can be linked to the CerviFix3.5mm and 4.0mm Systems, respectively. When used with the3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked tothe CerviFix 3.5mm and 4.0mm Systems, respectively. When usedwith the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod |
| systems can be linked to the Matrix System.In addition, Synthes USS 6.0mm rod systems can be interchangedwith all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3rods, which can only be used with Pangea.Synthes USS○ 6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening | |
| Click'X Monoaxial, Pangea, Pangea Monoaxial, USSPolyaxial, USS Iliosacral, ClampFixo 5.5mm Rod System: Matrixo 5.0mm Rod System: USS Small StatureCerviFixo 3.5mm Rod Systems: CerviFix, Axon, Synapseo 4.0mm Rod System: Synapse | |
| Comparison of thetechnologicalcharacteristics ofthe device to thepredicate device: | The design features, material, and indications for use of thesubject CoCr and Cp Ti-3 Rods are substantially equivalent to thepredicate devices identified. Additionally, the safety andeffectiveness of this system is adequately supported bydocumentation within this premarket notification. |
| Performance Data(Nonclinicaland/or Clinical) | Synthes conducted the following non-clinical testing: staticcompression bend, static torsion and dynamic compression bendin accordance with ASTM F1717 - 04/09. The conclusions drawnfrom testing demonstrate that the CoCr and Cp Ti-3 Rods aresubstantially equivalent to the predicate devices identified.Clinical data was not needed for this device. |
K 103287
Synthes 6.0 COCR and CP Ti-3 Rods 510(k) Summary
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K10 3287
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K 103287
Synthes 6.0 COCR and CP Ti-3 Rods 510(k) Summary
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KIO3287
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® SYNTHES
Spine
K103287 Synthes 6.0 COCR and CP Ti-3 Rods 510(k) Summary
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a bird or eagle, with its wings spread and head turned to the side.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-Q66-0609 Silver Spring, MD 20993-0002
Synthes Spine % Ms. Elizabeth Kierzek Associate Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K103287
Trade/Device Name: Synthes 6.0 CoCr and CP Ti-3 Rods Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: December 09, 2010 Received: December 10, 2010
Dear Ms. Kierzek:
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
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Page 2 - Ms. Elizabeth Kierzek
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.him 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.
A
vs. n h
.
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
JAN - 5 2011
10 Indications for Use Statement
K 103287 - -------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number:
Device Name: Synthes Pangea
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/illium), 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 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods. Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm 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.
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KI03287
SYNTHES®
Spine
Synthes USS
- 6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable 0 axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- O 5.5mm Rod System: Matrix
- 5.0mm Rod System: USS Small Stature o
CerviFix
- 3.5mm Rod Systems: CerviFix, Axon, Synapse o
- o 4.0mm Rod System: Synapse
Prescription Use X (21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND / OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-(if))
Division of Surgical, Orthopedic, and Restorative Devices
K103287 510(k) Number_
Ps 2 of
§ 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.