(77 days)
Not Found
No
The summary describes a mechanical spinal fixation device and its connectors. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing, not data analysis or image processing.
Yes
The device is a spinal fixation device intended as an adjunct to fusion for various conditions, indicating a direct role in treating and stabilizing a medical condition.
No
Explanation: The provided text describes the Synthes USS as a spinal fixation device, which is an implant used for surgical stabilization, not for diagnosing medical conditions. Its intended use is to aid in fusion for indications like degenerative disc disease, spondylolisthesis, trauma, and deformities.
No
The device description explicitly states that the device is a "Synthes USS Connector" which is a physical component made of TAN (Titanium-6 Aluminum-7 Niobium). The performance studies also describe non-clinical testing of this physical component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation. It is used in the body to provide structural support and aid in fusion.
- Device Description: The device is described as a connector made of titanium alloy, designed to link spinal rods. This is a physical implant.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided focuses on the mechanical properties and surgical application of the device, not on analyzing biological samples.
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 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Product codes
NKB, MNH, MNI, KWQ, KWP
Device Description
The Synthes USS Connector is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are rod-to-rod connectors which can connect spinal rods of 5.5mm diameter. The rod-to-rod connectors are comprised of TAN (Titanium-6 Aluminum- 7 Niobium, per ASTM F1295-05).
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
Synthes conducted non-clinical testing according to ASTM F1717- 10 – static compression bending, dynamic compression bending, and static torsion – to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified. Clinical data were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K963045, K992739, K031175, K082572, K092929, K100634, K100952, K111358, K113044, K113149
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.
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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black font. To the left of the word is a symbol of a circle with a figure inside. Below the word "SYNTHES" is the word "Spine" in a smaller font.
Spine
8 510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Hemal Mehta |
| Spine Regulatory Affairs Specialist | |
| Telephone: 610-719-5424 | |
| Facsimile: 610-719-5102 | |
| Email: mehta.hemal@synthes.com | |
| Date Prepared: | February 24, 2012 |
| Trade Name: | Synthes USS Connector |
| 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 Iliosacral and Polyaxial, K082572 | |
| Synthes Matrix System, K092929 | |
| Synthes Matrix System, K100634 | |
| Synthes Matrix System, K100952 | |
| Synthes USS Connectors, K111358 | |
| Synthes MIRS, K113044 | |
| Synthes USS Connectors, K113149 | |
| Device | |
| Description: | The Synthes USS Connector is an addition to Synthes' existing |
| non-cervical spinal fixation devices intended for posterior pedicle | |
| screw fixation (TI-S2/ilium), posterior hook fixation (T1-L5), or | |
| anterolateral fixation (T8-L5). These components are rod-to-rod | |
| connectors which can connect spinal rods of 5.5mm diameter. The | |
| rod-to-rod connectors are comprised of TAN (Titanium-6 Aluminum- | |
| 7 Niobium, per ASTM F1295-05). | |
| 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 | |
| Spine | |
| 510(k) Summary | |
| 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 mm/6.0mm parallel connectors, the | |
| Synthes USS 6.0 mm rod systems can be linked to the CerviFix | |
| 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm | |
| parallel connectors, the Synthes Small Stature USS can be linked | |
| to the CerviFix 3.5mm Systems. When used with the 5.0 | |
| mm/6.0mm parallel connectors, the Synthes Small Stature USS can | |
| be linked to the Synthes USS 6.0 mm rod systems. When used | |
| with the 5.5 mm/6.0mm parallel or extension connectors, Synthes | |
| USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 | |
| mm rod systems. 5.5 mm/5.5mm parallel or extension connectors | |
| can be used to link all Synthes USS 5.5 mm rod systems to one | |
| another. 6.0 mm/6.0mm parallel or extension connectors can be | |
| used to link all Synthes USS 6.0 mm rod systems to one another. | |
| Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm | |
| rod systems to one another. | |
| When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered | |
| rods, the Synthes USS 6.0 mm rod systems can be linked to the | |
| CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used | |
| with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the | |
| Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 | |
| mm and 4.0 mm Systems, respectively. When used with the 5.5 | |
| mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems | |
| can be linked to the Synthes USS 5.5 mm rod systems. | |
| In addition, Synthes USS 6.0 mm rod systems can be interchanged | |
| with all USS 6.0 mm rods and transconnectors except Synthes 6.0 | |
| mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, | |
| which can only be used with Pangea. Synthes USS 5.5 mm rod | |
| systems can be interchanged with all USS 5.5 mm rods and | |
| transconnectors. | |
| 510(k) Summary | |
| 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 Systems: Matrix, MIRS 5.0 mm Rod System: USS Small Stature CerviFix 3.5 mm Rod Systems: CerviFix, Axon, Synapse 4.0 mm Rod System: Synapse | |
| Comparison of | |
| the device to | |
| predicate | |
| device(s): | The intended use, indications for use, and materials of manufacture |
| of the subject devices are the same as the predicate Synthes USS. | |
| The overall design and function of the predicate(s) are unaffected | |
| by the current additions. | |
| Performance | |
| Data | |
| (Non-Clinical | |
| and/or Clinical): | Synthes conducted non-clinical testing according to ASTM F1717- |
| 10 – static compression bending, dynamic compression bending, | |
| and static torsion – to determine that the Synthes USS Connector is | |
| substantially equivalent to the predicate devices identified. Clinical | |
| data were not needed for this device. |
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K120571
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@ SYNTHES® Spine
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized emblem featuring a symbol that resembles a caduceus or a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Mr. Hemal Mehta Spine Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K120571
Trade/Device Name: Synthes USS Connector Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: February 24, 2012 Received: February 29, 2012
MAY 1 4 2012
Dear Mr. Mehta:
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
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/Resourcesfor You/Industry/default.htm.
Sincerely yours
For Robert D'Ascoli
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
3 SYNTHE: Spine
Indications for Use Statement 7
KI20571 510(k) Number: Device Name: Synthes USS Connector
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 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6
@ SYNTHES Spine
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Synthes USS
- 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS . variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
- 5.5 mm Rod Systems: Matrix, MIRS .
- 5.0 mm Rod System: USS Small Stature .
CerviFix
- 3.5 mm Rod Systems: CerviFix, Axon, Synapse .
- 4.0 mm Rod System: Synapse .
Prescription Use × (21 CFR 801 Subpart D)
K 120571
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 |
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