(80 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is a spinal fixation system indicated as an adjunct to fusion for various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion, all of which aim to treat or alleviate a disease or injury.
No
Explanation: The provided text describes the Synthes USS systems as "non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems... or as an anterolateral fixation system." These are implants used for spinal fusion and stabilization, not for diagnosing medical conditions.
No
The device description clearly states that the device consists of "a family of screws and connectors" and that the implants are manufactured from specific materials (Titanium Aluminum Niobium or Commercially Pure Titanium). This indicates a physical hardware device, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that the Synthes USS systems are "non-cervical spinal fixation devices" intended for "posterior pedicle screw fixation," "posterior hook fixation," or "anterolateral fixation." These are surgical implants used to stabilize the spine.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body.
- Clinical Performance: The document explicitly states that "Clinical data and conclusions were not needed for this device," which is typical for implantable devices that demonstrate substantial equivalence through bench testing. IVDs typically require clinical performance data related to their diagnostic accuracy.
Therefore, the Synthes USS systems are medical devices, but they fall under the category of surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click' X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degencrative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click' X, Click' X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral).
In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) can be interchanged with all USS 6.0 mm rods and transconnectors.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWQ, KWP
Device Description
The Synthes USS Polyaxial and Synthes USS Iliosacral Systems are additions to Synthes' existing posterior thoracolumbar spine systems. The Synthes USS Polyaxial and Synthes USS Iliosacral Systems consist of a family of screws and connectors designed to facilitate construct assembly and complex spine manipulation.
The systems are intended for additional rod fixation in the ilium and sacrum. The systems contain a variety of different connectors for attachment to the ilium and to the S2 pedicle. The implants are all manufactured from either Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295 or Commercially Pure Titanium (CpTi), the same as the predicates.
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 with the exception of the Small Stature USS which includes small stature and pediatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes USS Polyaxial and Synthes USS Iliosacral Systems are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were 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.
K010658, K963045, K002517, K992739, K031175, K052123, K010108, K022949
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for SYNTHES Spine. The word "SYNTHES" is in all caps and bolded. Below that is the word "Spine" in a smaller, cursive font.
6 510(k) Summary
NOV 2 4 2008
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Jason Lipman |
| Regulatory Affairs Specialist | |
| Telephone: 610-719-5629 | |
| Facsimile: 610-719-5102 | |
| Email: Lipman.Jason@Synthes.com | |
| Date Prepared: | September 3, 2008 |
| Trade Name: | Synthes USS Polyaxial System |
| Synthes USS Iliosacral System | |
| Classification: | 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 Fracture (K010658) |
| Synthes Universal Sacral System (K963045) | |
| Synthes USS VAS (K002517) | |
| Synthes Click'X (K992739, K031175) | |
| Synthes Pangea (K052123) | |
| Synthes USS (K010108, K022949) | |
| Device | |
| Description: | The Synthes USS Polyaxial and Synthes USS Iliosacral Systems are additions to |
| Synthes' existing posterior thoracolumbar spine systems. The Synthes USS | |
| Polyaxial and Synthes USS Iliosacral Systems consist of a family of screws and | |
| connectors designed to facilitate construct assembly and complex spine | |
| manipulation. | |
| The systems are intended for additional rod fixation in the ilium and sacrum. The | |
| systems contain a variety of different connectors for attachment to the ilium and | |
| to the S2 pedicle. The implants are all manufactured from either Titanium | |
| Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295 or Commercially Pure | |
| Titanium (CpTi), the same as the predicates. | |
| Intended Use/ | |
| Indications for | |
| Use: | The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small |
| Stature (which includes small stature and pediatric patients), USS VAS variable | |
| axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea | |
| Monoaxial, USS Polyaxial, and USS Iliosacral) are non-cervical spinal fixation | |
| devices intended for use as posterior pedicle screw fixation systems (T1- | |
| S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral | |
| fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature | |
| patients with the exception of the Small Stature USS. These devices are | |
| indicated as an adjunct to fusion for all of the following indications regardless of | |
| the intended use: 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). | |
| 510(k) Summary | |
| When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. | |
| When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral). | |
| In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) can be interchanged with all USS 6.0 mm rods and transconnectors. | |
| Comparison of | |
| the device to | |
| predicate | |
| device(s): | The Synthes USS Polyaxial and Synthes USS Iliosacral Systems are a result of design modifications to the predicate devices. It is substantially equivalent to the predicates in design, function, material, and intended use. |
| Performance | |
| Date | |
| (Non-Clinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Bench testing results demonstrate that the Synthes USS Polyaxial and Synthes USS Iliosacral Systems are substantially equivalent to the predicate devices. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
1
Image /page/1/Picture/5 description: The image shows the logo for Synthes Spine. The word "SYNTHES" is written in a bold, sans-serif font, with a registered trademark symbol to the right. Below the word "SYNTHES" is the word "Spine" in a smaller, italicized font.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2008
Synthes Spinc % Mr. Jason Lipman Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K082572
Trade/Device Name: Synthes USS Polyaxial System and Synthes USS Iliosacral System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system Regulatory Class: II Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 3, 2008 Received: September 9, 2008
Dear Mr. Lipman:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 - Mr. Jason Lipman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device acverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for SYNTHES Spine. The logo consists of a symbol on the left, followed by the word "SYNTHES" in bold, uppercase letters. Below "SYNTHES" is the word "Spine" in a smaller, cursive font. The logo is simple and professional, and it is likely used to represent a company that manufactures or sells spinal implants or other medical devices.
5 Indications for Use Statement
510(k) Number: K082572
Synthes USS Polyaxial System and Synthes USS Iliosacral System Device Name:
Indications for Use:
The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click' X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degencrative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click' X, Click' X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral).
In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, and USS Iliosacral) can be interchanged with all USS 6.0 mm rods and transconnectors.
Prescription Use X (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 General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K082572 |
CONFIDENTIAL Traditional 510(k) - Synthes USS Iliosacral and Polyaxial Systems
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