(100 days)
Not Found
No
The summary describes a physical interbody fusion device and its insertion instrument. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is used in the treatment of degenerative disc disease (DDD) to promote intervertebral body fusion, which directly addresses a medical condition.
No
The document describes the TM Ardis® Interbody System, which is a surgical implant used for spinal fusion. Its intended use is treatment for degenerative disc disease, not diagnosis.
No
The device description clearly states it is an implant made of Trabecular Metal Porous Tantalum and an inserter instrument made of surgical grade stainless steel and other materials, indicating it is a physical medical device, not software-only.
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 fusion, specifically treating degenerative disc disease. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as an interbody fusion device made of porous tantalum, designed to be implanted in the spine. This is a physical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a laboratory setting, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TM Ardis® Interbody System does not fit this description.
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 (comma separated list FDA assigned to the subject device)
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-S1. 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 is fabricated from surgical grade stainless steel and other applicable materials. TM Ardis Interbody System was cleared via 510(k) number K113561 on May 29, 2012.
The TM Ardis® Inserter instrument, that is the subject of this premarket notification, is intended for use with the TM Ardis® Interbody System. This instrument is designed specifically for use with the TM Ardis® Implants and is considered an accessory to the implants.
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
Patients should be 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of testing performed demonstrated that acceptance criteria were met in both Design Verification and Design Validation Testing and the modified TM Ardis Inserter adequately meet the requirements established in the design specifications for its mechanical performance. This testing demonstrated that the modified device is substantially equivalent to the predicate 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.
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
§ 888.3080 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
510(k) Summary
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Road
Parsippany, New Jersey 07054 | MAR 1 2013 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact Person: | Judith Rosen
Senior Regulatory Affairs Specialist
Telephone: (973) 576-0032 ext. 28138
Fax: (973) 884-8792
Email: judith.rosen@zimmer.com | |
| Date: | November 20, 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-S1. 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 is fabricated from surgical grade stainless steel and other applicable materials. TM Ardis Interbody System was cleared via 510(k) number K113561 on May 29, 2012.
The TM Ardis® Inserter instrument, that is the subject of this premarket notification, is intended for use with the TM Ardis® Interbody System. This instrument is designed specifically for use with the TM Ardis® Implants and is considered an accessory to the implants.
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.
1
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): Zimmer TMT, Inc. has submitted documentation demonstrating the substantial equivalence of the modified TM Ardis® Inserter instrument to the original version of the device included in K113561.
The unmodified and modified versions of the TM Ardis® Inserter instrument differ by a design change to the Inserter Locking Nut component and a dimentional change of the Inserter Body (Locking Nut) Housing. These changes provide additional leverage to release the implant from the instrument and reduce axial clearance between the Locking Nut and the Housing of the Inserter Body.
Both unmodified and modified versions of the TM Ardis® Inserter instrument have the same intended use, operate on the same technological principles, are manufactured from the same material (17-4 stainless steel), are cleaned and sterilized in the same manner with the same parameters, and have similar designs. The steel utilized for both versions meet ASTM A564/A564M: Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel and Heat-Resisting Steel Bars and Shapes.
Performance Data:
The results of testing performed demonstrated that acceptance criteria were met in both Design Verification and Design Validation Testing and the modified TM Ardis Inserter adequately meet the requirements established in the design specifications for its mechanical performance. This testing demonstrated that the modified device is substantially equivalent to the predicate device.
Substantial Equivalence:
Zimmer TMT, Inc. has submitted documentation demonstrating the substantial equivalence of the modified TM Ardis Inserter instrument to the original unmodified version of the device. The proposed TM Ardis® Inserter instrument is similar to the predicate version of the instrument in general form, materials, functional, sterilization and cleaning, and intended use. As demonstrated by supporting tests and descriptions, this design modification does not present new issues of safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle, following its curvature.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Zimmer Trabecular Metal Technology, Incorporated % Ms. Judith Rosen Senior Regulatory Affairs Specialist 10 Pomeroy Road Parsippany, New Jersey 07054
Re: K123602
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: February 6, 2013 Received: February 7, 2013
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. Iisting 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Judith Rosen
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The first part of the name, "Erin," is written in a simple, bold font. The second part of the name, "Keith," is written in a more decorative font, with geometric shapes and patterns incorporated into the letters.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K123602 510(k) Number (if known):
Device Name: TM Ardis® Interbody System
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-SI) 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.
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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
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