(180 days)
Not Found
No
The summary describes a physical interbody fusion device made of porous tantalum and surgical instrumentation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an intervertebral body fusion device used in the treatment of degenerative disc disease, which indicates a therapeutic purpose.
No
This device, the TM Ardis® Interbody System, is described as an intervertebral body fusion device used for treatment, specifically for spinal fusion. It is an implant designed to replace a disc and fuse bones, not to diagnose a condition.
No
The device description clearly states it is an implant made of Trabecular Metal Porous Tantalum and includes surgical instrumentation made of stainless steel. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Description and Intended Use: The TM Ardis® Interbody System is a physical implant designed for surgical insertion into the lumbosacral region of the spine to facilitate intervertebral body fusion. It is used in the treatment of degenerative disc disease.
- Lack of IVD Characteristics: The description does not mention any interaction with biological specimens outside of the body, analysis of samples, or providing diagnostic information based on such analysis.
The device is a surgical implant used for treatment, not for diagnosing a condition through in vitro testing.
N/A
Intended Use / Indications for Use
The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies: Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Product codes
MAX
Device Description
The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbosacral region (L2-S1)
Indicated Patient Age Range
Skeletally mature
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
Mechanical testing was performed on the TM Ardis® Interbody System in accordance with ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices. ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, Guidance for Industry and FDA Staff; Spinal Systems 510(k)s; May 3, 2004 and Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007 and was comprised of the following tests; Axial Compression - Static and Dynamic, Compression Shear - Static and Dynamic, Subsidence, Torsion - Static and Dynamic and Expulsion. The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
MAY 2 9 2012
510(k) Summary
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Road
Parsippany, New Jersey 07054 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Judith Rosen
Senior Regulatory Affairs Specialist
Telephone: (973) 576-0032 ext. 28138
Fax: (973) 884-8792
Email: judith.rosen@zimmer.com |
| Date: | May 25, 2012 |
| Trade Name: | TM Ardis® Interbody System |
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device, Lumbar 21 CFR § 888.3080, |
Device Panel/Product Code:Orthopedic / MAX
Device Description:
The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
Indications for Use:
The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies: Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Device Technological Characteristics and Comparison to Predicate Device(s):
The TM Ardis® Interbody System was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include the Ardis® Interbody System by Zimmer Spine
1
(K073202), Lucent® Lumbar Interbody System by Spinal Elements (K071724), TM-S Fusion Device by Zimmer Trabecular Metal Technology (K103033).
The TM Ardis® Interbody System has the identical material as previously cleared TM-S predicate devices. The intended use and indications for use of the subject device are similar to those of its predicate devices. The sizes, design features and overall geometry of the device in the current submission are similar to the cleared predicate devices.
There are no significant differences between the TM Ardis® Interbody System and the predicate devices currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy. The subject system is similar to its predicate devices with respect to intended use/indications for use. material, technological characteristics and basic principles of operation.
Performance Data:
Mechanical testing was performed on the TM Ardis® Interbody System in accordance with ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices. ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, Guidance for Industry and FDA Staff; Spinal Systems 510(k)s; May 3, 2004 and Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007 and was comprised of the following tests; Axial Compression - Static and Dynamic, Compression Shear - Static and Dynamic, Subsidence, Torsion - Static and Dynamic and Expulsion. The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance.
Substantial Equivalence:
The TM Ardis Interbody System is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation as demonstrated by the supporting performance testing data.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Trabecular Metal Technology, Incorporated % Ms. Judith Rosen Senior Regulatory Affairs Specialist 10 Pomeroy Road Parsippany, New Jersey 07054
MAY 2 9 2012
Re: K113561
Trade/Device Name: TM Ardis® Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 03, 2012 Received: May 04, 2012
Dear Ms. Rosen:
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 aboye) 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
3
Page 2 - Ms. Rosen
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 (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,
For Pat De Lee-
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Zimmer Trabecular Metal Technology, Inc. Traditional 510(k) - TM Ardis® Interbody System
Indications for Use
KIT3561 510(k) Number (if known):
Device Name: TM Ardis® Interbody System (TM TPLIF)
Indications for Use:
The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration i of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
Prescription Use X (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII3561 510(k) Number_