(342 days)
Not Found
No
The summary describes a mechanical vertebral body replacement device made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms or functionalities. The performance studies are based on mechanical bench testing.
Yes
The device is described as a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, providing anterior spinal column support. These are direct therapeutic actions to treat a medical condition.
No
The Synthes XRL device is a vertebral body replacement device, which is a therapeutic implant for spinal support, not a diagnostic tool for identifying medical conditions.
No
The device description explicitly states it is manufactured from PEEK, titanium, and tantalum, which are physical materials, not software. The performance studies also involve bench testing of physical properties like compression and torsion.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Synthes XRL device is a vertebral body replacement device for use in the spine to replace damaged or unstable vertebral bodies due to tumor or trauma. This is a surgical implant used in vivo (within the body).
- Device Description: The description details the materials and components of a physical implant designed to be surgically placed in the spine.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The Synthes XRL device is a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., USS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft).
The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Product codes
MQP
Device Description
The Synthes XRL System is an addition to Synthes' existing thoracolumbar vertebral body replacement systems. These implants are designed to replace a collapsed, damaged or unstable vertebral body and provide anterior spinal column support. These additional implants include telescoping cylindrical components with spiked endplates to grip the adjacent vertebral bodies. These devices are manufactured from PEEK (ASTM F1579-02e1 and ASTM D 6262) with titanium (ASTM F 1295) locking rings and stop pins and tantalum (ASTM F 560) radiopaque markers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Synthes performed the following testing based on ASTM F2077 and ASTM F1717:
• Static and Dynamic Axial Compression
• Static and Dynamic Axial Torsion
• Expulsion
• VBR Height-Locking Test
Bench testing results demonstrate that the Synthes XRL System is substantially equivalent to the predicate devices. Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003275, K003836, K041389, K050553, K062933
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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OCT 2 0 2011
K IO3320
PAGE 1 OF 2
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes USA |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Heather Guerin |
| Sr. Regulatory Affairs Specialist | |
| Telephone: 610-719-5432 | |
| Facsimile: 610-719-5102 | |
| Email: guerin.heather@synthes.com | |
| Date Prepared: | September 6, 2011 |
| Trade Name: | Synthes XRL System |
| Classification: | 21 CFR 888.3060-Spinal intervertebral body fixation orthosis |
| Class II | |
| Orthopedic and Rehabilitation Devices Panel | |
| Product Code: MQP | |
| Predicates: | Synthes SynMesh Spacer System (K003275) |
| Synthes Synex System (K003836) | |
| Synthes Contoured SynMesh (K041389) | |
| Alphatec NOVEL VBR Spinal System (K050553) | |
| Synthes Oracle Spacer System (K062933) | |
| Device | |
| Description: | The Synthes XRL System is an addition to Synthes' existing |
| thoracolumbar vertebral body replacement systems. These implants are | |
| designed to replace a collapsed, damaged or unstable vertebral body | |
| and provide anterior spinal column support. These additional implants | |
| include telescoping cylindrical components with spiked endplates to grip | |
| the adjacent vertebral bodies. These devices are manufactured from | |
| PEEK (ASTM F1579-02e1 and ASTM D 6262) with titanium (ASTM F |
- locking rings and stop pins and tantalum (ASTM F 560) radiopaque
markers. |
| Intended Use/
Indications for
Use: | The Synthes XRL device is a vertebral body replacement device intended
for use in the thoracolumbar spine (T1-L5) to replace a collapsed,
damaged or unstable vertebral body due to tumor or trauma (i.e.,
fracture). The Synthes XRL device is intended to be used with Synthes
supplemental internal fixation systems (e.g., USS, including Matrix and
Pangea, and TSLP). The interior of Synthes XRL can be packed with
bone (i. e., autograft or allograft).
The Synthes XRL device is designed to provide anterior spinal column
support even in the absence of fusion for a prolonged period. |
| 510(k) Summary | |
| Comparison of
the device to
predicate
device(s): | The Synthes XRL System is a result of design modifications to predicate
devices. It is substantially equivalent to the predicates in design, function,
material and intended use. |
| Performance
Data | Synthes performed the following testing based on ASTM F2077 and
ASTM F1717:
• Static and Dynamic Axial Compression
• Static and Dynamic Axial Torsion
• Expulsion
• VBR Height-Locking Test
Bench testing results demonstrate that the Synthes XRL System is
substantially equivalent to the predicate devices. Clinical data and
conclusions were not needed for this device. |
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K103320 PAGE 2 OF 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol resembling a caduceus, with three curved lines representing snakes or streams, and a base element that could be interpreted as a staff or a bowl.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Synthes USA % Ms. Heather Guerin Sr. Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K103320
Trade/Device Name: Synthes XRL System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 14, 2011 Received: October 17, 2011
Dear Ms. Guerin:
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 cranbe 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 not the Act
3
Page 2 - Ms. Heather Guerin
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/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.
Indications for Use Statement 4
510(k) Number: K103320 ______________________________________________________________________________________________________________________________________________________________________ (if known)
Device Name: Synthes Synthes XRL System
Indications for Use:
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., USS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft).
The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
| 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 Surgical, Orthopedic, and Restorative Devices
KIO3320 510(k) Number___