(88 days)
Not Found
Not Found
No
The document describes a passive implant (spinal cage) made of PEEK polymer. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as an intervertebral cage used to facilitate intervertebral body fusion for patients with degenerative disc disease, which constitutes a therapeutic intervention.
No
The device description clearly states its purpose as an "intercorporal implant for anterior cervical spondylodesis" and an "implant for the posterior stabilization of the lumbar spinal column," indicating it is a therapeutic device used for spinal fusion, not for diagnosing conditions.
No
The device description clearly states that the Zeus Cervical and Lumbar Cages are physical implants made of PEEK polymer, designed for surgical implantation in the spine. This indicates a hardware device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Zeus Cervical and Lumbar Cages: The provided description clearly states that these devices are implants designed to be surgically placed within the human body (the spine) to facilitate fusion. They are structural devices, not devices used to analyze biological samples.
The description focuses on the surgical use, materials, and mechanical properties of the implants, which are characteristic of medical devices intended for direct implantation, not IVDs.
N/A
Intended Use / Indications for Use
Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Anterior Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior approach. The Zeus Anterior Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Curved Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a transforaminal approach. The Zeus Curved Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Straight Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a posterior approach. The Zeus Straight Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The Zeus Small Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The top view is trapezoidal with a trapezoidal window for bone graft. The Zeus Cervical Cage has a flat top and bottom.
The Zeus Large/Extra Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using an Anterior Lumbar Interbody Fusion (ALIF) technique. To eliminate migration, ridges are incorporated on both the superior and inferior surfaces. Two large windows allow bony growth to form.
The Zeus Curved Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The Zeus Curved implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a T-LF approach.
The Zeus Straight Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The Zeus Straight implant incorporates ridges on both its superior and inferior surfaces to help eliminate migration. A large rectangular graft space help facilitate bony integration once implanted.
Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C3 to C7 disc levels), Lumbar spine (L2-S1, 12-51)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests performed according to ASTM F2077/F2267 indicate that the Interbody Zeus Innovations Intervertebral Fusion Devices meet required mechanical strengths. Some of the predicate devices have a different geometry than the Interbody Innovations Zeus Intervertebral Fusion Devices and do not have some test results reported in their PMA summaries, therefore, additional acceptance values for testing have been utilized.
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.
Not Found
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) Summarv for the Interbody Innovation Zeus Intervertebral Fusion Devices
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Interbody Innovation Zeus Intervertebral Fusion Devices.
Date Prepared: June 5, 2008
| 1. | Submitter: | Contact Person: |
|---|---|---|
| Interbody Innovations | J.D. Webb | |
| 303 Veterans Park Lane, Suite 1101 | The OrthoMedix Group, Inc. | |
| Midland, TX 79705 | 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | ||
| Telephone: 512-388-0199 |
| 2. | Trade name: | Interbody Innovation Zeus Intervertebral Fusion Devices |
|---|---|---|
| Common Name: | intervertebral body fusion device | |
| Classification Name: | intervertebral body fusion device - cervical | |
| Intervertebral body fusion device - lumbar | ||
| 21 CFR section 888.3080 | ||
| ODP/MAX | ||
| Class II |
ന Predicate or legally marketed devices which are substantially equivalent:
The Interbody Innovations Zeus Intervertebral Fusion Devices are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.
4. Description of the device:
The Zeus Small Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The top view is trapezoidal with a trapezoidal window for bone graft. The Zeus Cervical Cage has a flat top and bottom.
The Zeus Large/Extra Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using an Anterior Lumbar Interbody Fusion (ALIF) technique. To eliminate migration, ridges are incorporated on both the superior and inferior surfaces. Two large windows allow bony growth to form.
The Zeus Curved Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The Zeus Curved implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a T-LF approach.
The Zeus Straight Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The Zeus Straight implant incorporates ridges on both its superior and inferior surfaces to help eliminate migration. A large rectangular graft space help facilitate bony integration once implanted..
Materials:
PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
5. Intended Use:
Zeus Small Cervical Cage s are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is
pg 1 of 2
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1181614
defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Lumbar Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior/transforaminal/posterior approach. The Zeus Lumbar Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices: 6. The Interbody Innovations Zeus Intervertebral Fusion Devices have indications and material, and similar designs as previously cleared devices.
7. Summary of Non-clinical Tests
Tests performed according to ASTM F2077/F2267 indicate that the Interbody Zeus Innovations Intervertebral Fusion Devices meet required mechanical strengths. Some of the predicate devices have a different geometry than the Interbody Innovations Zeus Intervertebral Fusion Devices and do not have some test results reported in their PMA summaries, therefore, additional acceptance values for testing have been utilized.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, vectorized design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
SEP - 5 2008
Interbody Innovations, LLP % Mr. J.D. Wcbb The Orthomedix Group, Inc. 1001 Oakwood Blvd
Re: K081614
Round Rock, Texas 78681
Trade/Device Name: Zeus Small Cervical Cage, Zeus Anterior Lumbar Cage, Zeus Curved Lumbar Cage, Zeus Straight Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: June 5, 2008 Received: June 9, 2008
Dear Mr. Webb:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mullinax
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _K08)614
Device Name: Zeus Small Cervical Cages
Indications for Use:
Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR MNIM
Division of General, Restorative, and Neurological Devices
510(k) Number K080614
5
રેજી દાપ 510(k) Number (if known):
Device Name: Zeus Anterior Lumbar Cage
Indications for Use:
The Zeus Anterior Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior approach. The Zeus Anterior Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR MNM
510(K) L
6
KORIBIT 510(k) Number (if known):
Device Name: Zeus Curved Lumbar Cage
Indications for Use:
The Zeus Curved Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a transforaminal approach. The Zeus Curved Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR MNM
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number L081614
7
kosibili 510(k) Number (if known):
Device Name: ___ Zeus Straight Lumbar Cage
Indications for Use:
The Zeus Straight Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a posterior approach. The Zeus Straight Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR MNM
and Neurological
510(k) Number K080614