(245 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
Explanation: The device is indicated as an adjunct to fusion for various medical conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion, which are all therapeutic in nature.
No
Explanation: The device is described as a spinal fixation system, intended for surgical use as an adjunct to fusion for various spinal conditions, not for diagnosing them.
No
The device description explicitly states that the device consists of "implants" which are physical components made from Titanium Aluminum Niobium. This indicates a 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 tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
- Device description and intended use: The text clearly describes the Synthes USS and ClampFix systems as spinal fixation devices intended for surgical implantation to stabilize the spine. They are used as an adjunct to fusion for various spinal conditions.
- Lack of mention of biological samples or testing: There is no mention of the device interacting with or analyzing biological samples from a patient. Its function is purely mechanical and structural.
Therefore, the Synthes USS and ClampFix systems fall under the category of surgical implants/devices, 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, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/illium), 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, 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 3.5/6.0-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, USS Iliosacral, and ClampFix) 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 Cerviflix 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, USS fliosacral, and ClampFix).
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, USS Iliosacral, and ClampFix) 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 ClampFix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The ClampFix implants consist of a family of clamps designed to facilitate construct assembly and complex spine manipulation. The new implants for the system are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior pedicle screw fixation systems (T1-S2/illium), posterior hook fixation system (T1-L5), or as an anterolateral fixation system (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 ClampFix System is 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.
Synthes USS Fracture (K010658), Synthes Universal Sacral System (K963045), Synthes Click'X (K992739), Synthes ClampFix (K082914), Synthes USS (K022949)
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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.
NOV - 6 2009
Page X
5 510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes USA |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Jason Lipman |
| Senior Regulatory Affairs Specialist | |
| Telephone: 610-719-5629 Facsimile: 610-719-5102 | |
| Email: Lipman.Jason@Synthes.com | |
| Date Prepared: | March 4, 2009 |
| Trade Name: | Synthes ClampFix 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 Click'X (K992739) | |
| Synthes ClampFix (K082914) | |
| Synthes USS (K022949) | |
| Device Description: | The Synthes ClampFix System is an addition to Synthes' existing posterior |
| thoracolumbar spine systems. The ClampFix implants consist of a family of | |
| clamps designed to facilitate construct assembly and complex spine | |
| manipulation. The new implants for the system are manufactured from Titanium | |
| Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, 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, USS Iliosacral, and ClampFix) 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). | |
| 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, USS Iliosacral, and ClampFix) can be linked to the CerviFix System. | |
| 510(k) Summary | |
| 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, USS Iliosacral, and ClampFix). |
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, USS Iliosacral, and
ClampFix) can be interchanged with all USS 6.0 mm rods and transconnectors. |
| Comparison of
the device to
predicate
device(s): | The Synthes ClampFix System is 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 ClampFix System is
substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
Page 17 of 40
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Image /page/2/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Synthes USA % Mr. Jason Lipman, RAC Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
NOV ~ 6 2009
Re: K090605
Trade/Device Name: Synthes Clampfix System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ, KWP Dated: September 11, 2009 Received: September 14, 2009
DEPARTMENT OF HEALTH & HUMAN SERVICES
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, listing 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 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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 – Mr. Jason Lipman
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/cdrh/mdr/ 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/cdrlv/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SYNTHES®
Indications for Use Statement 4
510(k) Number: (if known)
Device Name: Synthes ClampFix System
K 090605
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, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/illium), 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, Schevermann'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 3.5/6.0-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, USS Iliosacral, and ClampFix) 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, USS fliosacral, and ClampFix).
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, USS Iliosacral, and ClampFix) 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)
H. h
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090605