(125 days)
Not Found
No
The summary describes a physical interbody fusion device and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the treatment of degenerative disc disease and acts as an intervertebral body fusion device, which directly addresses a medical condition.
No
The device is an intervertebral body fusion device used in the treatment of degenerative disc disease, not a device for diagnosing conditions.
No
The device description clearly details physical implants made of PEEK and tantalum, as well as surgical instruments made of aluminum, stainless steel, and polymeric materials. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Ardis Interbody System is not an In Vitro Diagnostic (IVD) device.
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.
- Ardis Interbody System Function: The Ardis Interbody System is a surgical implant designed to be placed within the human body (specifically, the spine) to facilitate bone fusion. It is a physical device used in a surgical procedure, not a device used to analyze biological samples outside the body.
- Intended Use: The intended use clearly states it's for intervertebral body fusion in the lumbosacral region to treat degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a specimen.
- Device Description: The description details a physical implant made of PEEK and instruments for its insertion. It does not describe any components for collecting or analyzing biological samples.
Therefore, the Ardis Interbody System falls under the category of a surgical implant or medical device used in a surgical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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-S () 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 Ardis Interbody System 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 Ardis® Interbody System is a device for interbody fusion of the anterior column of the spine. The Ardis implant may be used to replace the disc. These cages are hollow so that bone can grow through the device. fusing the adjacent bony surfaces.
The Ardis implant is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths and heights. Zimmer Spine designed Ardis to be placed through a posterior or transforaminal approach and to address vertebrae in the lumbosacral region of the spine. The system contains implants of various sizes to accommodate different patient anatomy. and instruments for site preparation. trialing and insertion. The device is crafted from (polvetheretherketone) PEEK-OPTIMA (ASTM F2026). As PEEK-OPTIMA is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires and beads (ASTM F560) that are press fit into small holes in the implant. Additionally. the Zimmer Spine Ardis® Interbody System includes the instrumentation to facilitate the implantation of the system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel. and/or polvmeric materials.
The Ardis Inserter that is the subject of this premarket notification is an instrument intended for use with the Ardis® Interbody System. The instrument is designed specifically to implant the PEEK interbody device into a prepared disc space. The inserter threads into the posterior hole of the PEEK implant securing the implant in place with a secondary locking (anti-rotation) mechanism. The inserter design is specific to the width measurement of the PEEK implant. A 9mm width implant will be used in conjunction with the PEEK Ardis Inserter, 9mm, and an 1 Imm implant will be inserted using the PEEK Ardis Inserter, 1 I mm.
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)
Design Verification Testing and Design Validation studies conducted on the Ardis Interbody System implants and instruments demonstrated the performance of the subject device was substantially equivalent in design, function, material, biocompatibility and sterilization when compared 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
SEP 0 3 2013
510(K) Summary Of Safety And Effectiveness
Submitter:
Zimmer Spine, Inc. 7375 Bush Lake Rd. Minneapolis. MN 55439
Establishment Registration Number: 1649384
Contact Personnel:
Jon Gilbert Director Regulatory Affairs Telephone: (952) 830-6385 Fax: (952) 837-6985
Date:
2 August 2013
Trade Name: Ardis® Interbody System
Common Name: Spinal Intervertebral Body Fusion Device
Classification Name and Reference:
Ardis® Interbody System is classified as Class II (MAX). Spinal Intervertebral Body Fusion Device, 21 CFR § 21 CFR 888.3080.
Predicate Device:
Zimmer Spine Ardis@ Spacer System (a.k.a. Ardis Interbody System), K073202 (1/30/08 & Add to file 11/17/11)
Device Description::
The Ardis® Interbody System is a device for interbody fusion of the anterior column of the spine. The Ardis implant may be used to replace the disc. These cages are hollow so that bone can grow through the device. fusing the adjacent bony surfaces.
Ardis Inserter, 510(k) K131242 Al response
287 of 361
1
The Ardis implant is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths and heights. Zimmer Spine designed Ardis to be placed through a posterior or transforaminal approach and to address vertebrae in the lumbosacral region of the spine. The system contains implants of various sizes to accommodate different patient anatomy. and instruments for site preparation. trialing and insertion. The device is crafted from (polvetheretherketone) PEEK-OPTIMA (ASTM F2026). As PEEK-OPTIMA is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires and beads (ASTM F560) that are press fit into small holes in the implant. Additionally. the Zimmer Spine Ardis® Interbody System includes the instrumentation to facilitate the implantation of the system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel. and/or polvmeric materials.
The Ardis Inserter that is the subject of this premarket notification is an instrument intended for use with the Ardis® Interbody System. The instrument is designed specifically to implant the PEEK interbody device into a prepared disc space. The inserter threads into the posterior hole of the PEEK implant securing the implant in place with a secondary locking (anti-rotation) mechanism. The inserter design is specific to the width measurement of the PEEK implant. A 9mm width implant will be used in conjunction with the PEEK Ardis Inserter, 9mm, and an 1 Imm implant will be inserted using the PEEK Ardis Inserter, 1 I mm.
Indications for Use:
The 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-S () 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 Ardis Interbody System 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 Spine has submitted documentation demonstrating the substantial equivalence between subject and predicate devices. The unmodified versions of the instrument and the proposed version have the same intended use. operate on the same technological principles, are biocompatible for the expected patient contact profile and are cleaned and sterilized in the same way with the same parameters. The unmodified versions of the Ardis® Interbody System differ only in design and materials.
2
Performance Date:
Design Verification Testing and Design Validation studies conducted on the Ardis Interbody System implants and instruments demonstrated the performance of the subject device was substantially equivalent in design, function, material, biocompatibility and sterilization when compared to the predicate device.
Substantial Equivalence:
Zimmer Spine Inc. has submitted documentation demonstrating the substantial equivalence of the modified and unmodified versions of the Ardis® Interbody System. The proposed Inserter instrument is similar to the unmodified version of the instrument in general form, 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.
Ardis Inserter, 510(k) K131242 Al response
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the perimeter, and a stylized symbol in the center. The symbol is composed of three curved lines that resemble a person embracing the world. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
September 3, 2013
Zimmer Spine. Incorporated % Mr. Jonathan Gilbert Director, Regulatory Affairs 7375 Bush Lake Road Minneapolis. Minnesota 55439
Re: K131242
Trade/Device Name: Ardis " Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 2. 2013 Received: August 5, 2013
Dear Mr. Gilbert:
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 cither 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Mr. Jonathan Gilbert
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plcase 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ K131242
Device Name: Ardis® Interbody System
Indications for Use:
The 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 I 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 Ardis Interbody System 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 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices