(264 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a spinal fusion cage, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is indicated for intervertebral body fusion of the lumbar spine for the treatment of degenerative disc disease, which is a medical condition, and is designed to stabilize spinal segments and promote fusion, thereby having a therapeutic effect.
No
This device is an intervertebral body fusion cage intended for surgical implantation to promote spinal fusion, not to diagnose a condition.
No
The device description explicitly states it consists of "various sized, titanium coated, PEEK intervertebral body fusion cages, titanium anchoring plates for integrated fixation, and associated instrumentation," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device, the Avenue P Cage System, is an implantable medical device used in surgery to fuse vertebrae in the lumbar spine. It is a physical device that is placed inside the body, not a tool for analyzing biological samples.
The description clearly outlines its use in a surgical procedure for treating degenerative disc disease and promoting spinal fusion. This falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Avenue P is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.
Product codes
OVD, MAX
Device Description
The Avenue® P Cage System consists of various sized, titanium coated, PEEK intervertebral body fusion cages, titanium anchoring plates for integrated fixation, and associated instrumentation. The system is intended to be used to stabilize lumbosacral spinal segments, promote spinal fusion in combination with bone graft and to restrict motion at the implanted vertebral level.
The Avenue® P cages have been designed for use with optional VerteBRIDGE® integrated fixation anchoring plates. Upon insertion, the VerteBRIDGE® anchoring plate provides and maintains additional stability and expulsion resistance by direct purchase into the bony vertebral endplates.
The base material of the Avenue® P Cage System implant is polyetheretherketone (PEEK-OPTIMA LT1) which conforms to ASTM F2026-12. This PEEK base is coated on the superior and inferior surfaces with a plasma sprayed, commercially pure titanium (SPONDYCOAT-T 371A) conforming to ASTM F1580-12.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
Indicated Patient Age Range
skeletally mature 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
To support substantial equivalence, mechanical testing of the intervertebral body fusion implants of the subject Avenue P Cage System were assessed and tested appropriately in accordance with ASTM standards. The assessment concluded that intervertebral body fusion device are substantially equivalent to the identified predicates for use with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing included assessments per ASTM F2077 (axial compression shear, and torsion). MR Safety testing was conducted per ASTM F2052 (Displacement Force), ASTM F2213 (Torque), ASTM F2119 (Image Artifact), and ASTM F2182 (RF heating). In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K151773, K150061, K153695, K142645, K151934
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
January 15, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zimmer Biomet Spine, Inc. Mr. Alex Pawlowski Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K181096
Trade/Device Name: Avenue® P Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 14, 2018 Received: December 18, 2018
Dear Mr. Pawlowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181096
Device Name Avenue® P Cage System
Indications for Use (Describe)
Avenue P is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Zimmer Biomet, a medical device company. The logo consists of a stylized letter Z in blue, followed by the company name in gray. Above the logo, the text "K181096 Page 1 of 3" is visible, likely indicating a document identifier and page number.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | April 25, 2018 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc. |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | Alex Pawlowski |
| Regulatory Affairs Specialist | |
| Phone: 303-533-1062 | |
| Fax: 303-465-5522 | |
| Trade Name | Avenue® P Cage System |
| Common Name | Intervertebral body fusion device |
| Device Class | Class II |
| Classification Name | OVD - Intervertebral Body Fusion Device With Integrated Fixation, Lumbar |
| (21 CFR 888.3080) | |
| MAX – Intervertebral Body Fusion Device With Bone Graft, Lumbar | |
| (21 CFR 888.3080) | |
| Device Panel | Orthopedic |
Device Description & Technological Characteristics:
The Avenue® P Cage System consists of various sized, titanium coated, PEEK intervertebral body fusion cages, titanium anchoring plates for integrated fixation, and associated instrumentation. The system is intended to be used to stabilize lumbosacral spinal segments, promote spinal fusion in combination with bone graft and to restrict motion at the implanted vertebral level.
The Avenue® P cages have been designed for use with optional VerteBRIDGE® integrated fixation anchoring plates. Upon insertion, the VerteBRIDGE® anchoring plate provides and maintains additional stability and expulsion resistance by direct purchase into the bony vertebral endplates.
The base material of the Avenue® P Cage System implant is polyetheretherketone (PEEK-OPTIMA LT1) which conforms to ASTM F2026-12. This PEEK base is coated on the superior and inferior surfaces with a plasma sprayed, commercially pure titanium (SPONDYCOAT-T 371A) conforming to ASTM F1580-12.
4
Image /page/4/Picture/1 description: The image shows the logo of Zimmer Biomet, a medical device company. The logo consists of a stylized blue "Z" followed by the text "ZIMMER BIOMET" in a sans-serif font. Above the logo, the text "K181096 Page 2 of 3" is visible, likely indicating a document number and page number.
Intended Use / Indications for Use:
Avenue P is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.
Summary of Technological Characteristics:
The technological characteristics of the subject Avenue® P cage system components remain the same as, or similar to, the primary predicate, CONCORDE® Bullet (K151773), and the additional predicates, Lucent Ti-Bond Systems (K150061), Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to seek clearance for the Avenue® P Cage System.
Summary of Performance Data:
To support substantial equivalence, mechanical testing of the intervertebral body fusion implants of the subject Avenue P Cage System were assessed and tested appropriately in accordance with ASTM standards. The assessment concluded that intervertebral body fusion device are substantially equivalent to the identified predicates for use with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing included assessments per ASTM F2077 (axial compression shear, and torsion). MR Safety testing was conducted per ASTM F2052 (Displacement Force), ASTM F2213 (Torque), ASTM F2119 (Image Artifact), and ASTM F2182 (RF heating). In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate devices.
5
Image /page/5/Picture/1 description: The image shows the Zimmer Biomet logo, which consists of a blue stylized "Z" and the text "ZIMMER BIOMET" in a sans-serif font. Above the logo, there is the text "K181096" and "Page 3 of 3". The logo and text are likely part of a document or presentation.
Substantial Equivalence:
The subject Avenue® P Cage System implants have intended use, indications, technological characteristics, and principles of operation as the previously cleared CONCORDE® Bullet (K151773), Lucent® Ti-Bond Systems (K150061), Biomet Spine Fusion System (K153695), Avenue T TLF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934). Additionally, the subject Avenue® P Cage System and it's predicates are regulated under 21 CFR 888.3080. The subject Avenue® P components do not raise any new issues of safety or effectiveness when compared to the cited predicates. Performance data presented also demonstrated comparable properties to the previously cleared devices.
Conclusion:
The Avenue® P Cage System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the CONCORDE® Bullet, Lucent Ti-Bond, Biomet Spine Fusion, Avenue T TLIF Cage and ROI-C Titanium-Coated Implant Systems which have been cleared for intervertebral body fusion. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.