(65 days)
Not Found
Not Found
No
The summary describes a mechanical spinal fixation device and its materials. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a spinal fixation device intended as an adjunct to fusion for various spinal conditions, which are therapeutic goals.
No
The device is described as a spinal fixation device, intended for surgical implantation to treat various spinal conditions, not to diagnose them.
No
The device description clearly states it is comprised of physical materials (commercially pure titanium grade 3 and Cobalt Chrome Molybdenum) and is intended for physical implantation as spinal fixation devices. This indicates it is a hardware device, not software-only.
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 for diagnosis, monitoring, or screening.
- Device description and intended use: The text clearly describes the Synthes USS as a system of spinal fixation devices (rods, screws, hooks, etc.) intended for surgical implantation to stabilize the spine. This is a surgical implant, not a device that analyzes biological samples.
- Lack of mention of biological samples or analysis: The text does not mention any interaction with or analysis of biological specimens.
Therefore, the Synthes USS falls under the category of a surgical implant or medical device used for structural support, not an In Vitro Diagnostic device.
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 3.5/6.0mm 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.
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
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWQ, KWP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (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)
Synthes conducted the following non-clinical testing: static compression bend, static torsion and 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.
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.
Not Found
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
K103287
SYNTHES
Spine
:
JAN - 5 2011
Spine
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Elizabeth Kierzek
Associate Regulatory Affairs Specialist
Phone: 610-719-5722
Fax: 610-719-5102
Email: Kierzek.Elizabeth@synthes.com |
| Date Prepared: | December 9, 2010 |
| Trade Name: | Synthes Pangea System |
| Classification: | Orthopaedic and Rehabilitation Devices Panel
Class III |
| | 21 CFR 888.3070 - Pedicle screw spinal system
Product Code: NKB, MNH, MNI |
| | 21 CFR 888.3060 - Spinal intervertebral body fixation orthosis
Product Code: KWQ |
| | 21 CFR 888.3050 - Spinal interlaminal fixation orthosis
Product Code: KWP |
| | Predicate Devices: |
| Device
Description: | 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. |
| 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 3.5/6.0mm 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.
Synthes USS
○ 6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening |
| | Click'X Monoaxial, Pangea, Pangea Monoaxial, USS
Polyaxial, USS Iliosacral, ClampFix
o 5.5mm Rod System: Matrix
o 5.0mm Rod System: USS Small Stature
CerviFix
o 3.5mm Rod Systems: CerviFix, Axon, Synapse
o 4.0mm 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 CoCr and Cp Ti-3 Rods are 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
(Nonclinical
and/or Clinical) | Synthes conducted the following non-clinical testing: static
compression bend, static torsion and 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.
Clinical data was not needed for this device. |
K 103287
Synthes 6.0 COCR and CP Ti-3 Rods 510(k) Summary
......
1
K10 3287
@ SYNTHES" Spine
K 103287
Synthes 6.0 COCR and CP Ti-3 Rods 510(k) Summary
Pg 2 of 3
2
KIO3287
:
® SYNTHES
Spine
K103287 Synthes 6.0 COCR and CP Ti-3 Rods 510(k) Summary
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Pg 3 of 3
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... ... ... ... .... ..............
3
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
4
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
5
® 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.
6
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