(186 days)
Not Found
No
The summary describes a mechanical spinal fixation device and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
This device is designed to treat various spinal conditions, including degenerative disc disease, spondylolisthesis, trauma, deformities, and tumors, by providing fixation and aiding in fusion.
No
The device is described as a spinal fixation device, which is an implant used for treatment (fusion and stabilization), not for diagnosing conditions.
No
The device description clearly states it is comprised of physical components (snap-on parallel connectors made of TAN and Nitinol) intended for spinal fixation. This indicates a hardware medical device, not a software-only one.
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: The description clearly states that the Synthes USS are "non-cervical spinal fixation devices" and describes their use in surgical procedures involving the spine (posterior pedicle screw fixation, posterior hook fixation, anterolateral fixation).
- Intended Use/Indications for Use: The intended use and indications all relate to providing mechanical support and stabilization to the spine in various conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion. This is a therapeutic function, not a diagnostic one based on in vitro analysis of specimens.
The device is a surgical implant used in the body, not a device used to test samples from 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 3.5/6.0mm 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 5.5/6.0mm parallel connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm parallel connectors can be used to link all Synthes USS 6.0mm rod systems to one another.
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 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 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
Product codes
NKB, MNH, MNI, KWQ, KWP
Device Description
The Synthes USS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are snap-on parallel connectors which can connect spinal rods of the same or different diameters. The snap-on parallel connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05) and Nitinol (per ASTM F2063-05).
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
Not Found
Key Metrics
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, K100634, Synthes Matrix System, K100952, Synthes 6.0 CoCr and CP Ti-3 Rods, K103287
Reference Device(s)
Not Found
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.
0
@ SYNTHES*
Spine Spine
510(k) Summary
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | |
| 510(k) Contact: | Heather Guerin
Spine Senior Regulatory Affairs Specialist
Telephone: 610-719-5432
Facsimile: 610-719-5102
Email: guerin.heather@synthes.com |
| Date Prepared: | November 17, 2011 |
| Trade Name: | Synthes Universal Spine System (USS) |
| 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 |
| 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, K100634
Synthes Matrix System, K100952
Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 |
| Device
Description: | The Synthes USS is an addition to Synthes' existing non-cervical spinal
fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium),
posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These
components are snap-on parallel connectors which can connect spinal
rods of the same or different diameters. The snap-on parallel connectors
are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM
F1295-05) and Nitinol (per ASTM F2063-05). |
| 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, Scheuerrnann's |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird, with the text following the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 12 2012
Synthes Spine % Ms. Heather Guerin 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K111358
Trade/Device Name: Synthes USS Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 20, 2011 Received: September 21, 2011
Dear Ms. Guerin:
This letter corrects our previous letter dated November 18, 2011, which cited incorrectly the Trade/Device Name for the subject device.
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.
2
Page 2 - Ms. Heather Guerin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advisod mar 1 Dri 3 issualles complies with other requirements of the Act that I DA has made a down regulations administered by other Federal agencies. You must or any I catal statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K I art 607), idooiing (21 OFF 803); good manufacturing practice requirements as set device-related adverse ovents) (21 CFR Part 820); and if applicable, the electronic forth in the quality bysteins (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 11 you desire specific ad rios to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for go to mig.//www.radi.gov.retal.gov.retail.is (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 I ou may oount only generational 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 yours,
Mark M. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: K111358
Device Name: Synthes Universal Spine System (USS)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1 The Synthes Ooo are non Gelfon (T1-L5), or anterolateral fixation (TB-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature to onelialry matients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative discogenic back pain with degeneration of the disc indications: degenerative end 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 iniked 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 paraliel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm parallel connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm parallel connectors can be used to link all Synthes USS 6.0mm rod systems to one another.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can villen abouting the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and be innice to the Services and he 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 6.0mm 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 axis . o.omnin Not Cyclerie: Jure, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- 5.5mm Rod System: Matrix ◆
- 5.0mm Rod System: USS Small Stature ●
CerviFix
- 3.5mm Rod Systems: CerviFix, Axon, Synapse ●
- 4.0mm Rod System: Synapse ●
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, and Restorative Devices