(104 days)
Not Found
No
The summary describes a physical interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is intended for intervertebral body fusion procedures to treat degenerative disc disease, which is a therapeutic intervention.
No
Explanation: The device is an intervertebral body fusion system, intended for therapeutic use to maintain disc space distraction, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Hybrid Cervical Interbody System" made of PEEK and Titanium alloy, which are physical materials, not software. The performance studies also describe mechanical testing of physical implants.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Gemini-C Hybrid Cervical Interbody System is an implantable device used in surgical procedures to fuse vertebrae in the cervical spine. It is a physical device inserted into the body, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
Product codes
ODP
Device Description
The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti-6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at disc levels from C2 to T1
Indicated Patient Age Range
skeletally mature adults
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)
Non-clinical Test Summary: The following analyses were conducted: • Static and dynamic compression (ASTM F2077) • Static and dynamic compression shear (ASTM F2077) • Static and dynamic torsion (ASTM F2077) • Subsidence (ASTM F2267) • Expulsion testing (ASTM Draft Standard F-04.25.02.02). The results of these evaluations indicate that the Gemini-C Hybrid Cervical Interbody System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150619, K073351, K100889, P980048, K083425, P960025, K091088, K140280, K121741
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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osseus Fusion Systems, LLC % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
July 3, 2017
Re: K170844
Trade/Device Name: Gemini-C Hybrid Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 5, 2017 Received: June 7, 2017
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, 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 801); medical device reporting (reporting of medical device-
Image /page/0/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The seal is presented in black and white.
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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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
K170844
Device Name
Gemini-C Hybrid Cervical Interbody System
Indications for Use (Describe)
The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
ا Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary: Gemini-C Hybrid Cervical Interbody System
| Date Prepared | June 5, 2017 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC |
| 2703 Mockingbird Lane, Suite 102 | |
| Dallas, TX 75235 | |
| 214-395-0100 Tele | |
| email: rpace@osseus.com | |
| Primary Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Gemini-C Hybrid Cervical Interbody System |
| Common Name | intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | • CONSTRUX Mini PEEK Ti Spacer System (K150619) |
| Additional Predicate | |
| Devices | • Crystal Cervical Cage (K073351) |
| • Endoskeleton® TC (K100889) | |
| • BAK/Cervical Interbody Fusion (P980048) | |
| • Fusion Advantage Interbody Cages, (K083425) | |
| • Brantigan I/F Cage (P960025) | |
| • LDR Spine Cervical Interbody Fusion System (K091088) | |
| • Nanovis FortiCore™ (K140280) | |
| • 4-Webb Cervical STS Interbody Fusion Device (K121741) | |
| Device Description | The Osseus Fusion Systems' Gemini-C Hybrid Cervical Interbody System is used to |
| maintain disc space distraction in skeletally mature adults requiring intervertebral body | |
| fusion. This system includes three design configurations: 1) PEEK, 2) Titanium alloy (Ti- | |
| 6Al-4V ELI), and 3) Hybrid PEEK/Titanium alloy. The implants are available in a range of | |
| footprints and heights to suit the individual pathology and anatomical conditions of the | |
| patient. The implants have a hollow center to allow placement of bone graft. | |
| Materials | • SOLVAY ZENIVA ZA-500 PEEK (ASTM F2026) |
| • Ti-6A-4V ELI (ASTM F136) | |
| • Tantalum (ASTM F560) | |
| • Stainless steel (ASTM F899) | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Gemini-C Hybrid Cervical Interbody System is substantially equivalent to the |
| predicate devices in terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | The Gemini-C Hybrid Cervical Interbody System is indicated for intervertebral body fusion |
| procedures in skeletally mature patients with degenerative disc disease (DDD) at one or | |
| two contiguous levels within the cervical spine at disc levels from C2 to T1. Degenerative | |
| disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the | |
| disc confirmed by patient history and radiographic studies. This device is intended for use | |
| with autogenous bone graft and/or allograft comprised of cancellous and/or | |
| corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as | |
| the White Pearl Preferred Angle Anterior Cervical Plate). Patients should have had at least | |
| six weeks of non-operative treatment prior to treatment with intervertebral cages. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Static and dynamic compression (ASTM F2077) | |
| • Static and dynamic compression shear (ASTM F2077) | |
| • Static and dynamic torsion (ASTM F2077) | |
| • Subsidence (ASTM F2267) | |
| • Expulsion testing (ASTM Draft Standard F-04.25.02.02) |
The results of these evaluations indicate that the Gemini-C Hybrid Cervical Interbody
System is equivalent to predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Osseus Fusion Systems, LLC considers the Gemini-C Hybrid Cervical Interbody System
to be equivalent to the predicate devices listed above. This conclusion is based upon the
similarities between the Gemini-C and predicates in terms of principles of operation,
technology, materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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