(47 days)
No
The device description and performance studies focus on the mechanical properties and intended use as a physical implant for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to be used as an "adjunct to fusion of the cervical spine," and states its purpose is "temporary stabilization of the anterior spine during the development of cervical spinal fusion" for various medical conditions, indicating a therapeutic role.
No
This device is described as an anterior cervical plate system intended for surgical fixation and fusion, not for diagnosing medical conditions. It is a therapy device.
No
The device description explicitly states it is comprised of cervical plates and bone screws constructed of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the APOLLO™ Anterior Cervical Plate (ACP) System is for anterior screw fixation to the cervical spine as an adjunct to fusion. This describes a surgical implant used to stabilize the spine during the healing process.
- Device Description: The device is described as being comprised of cervical plates and bone screws. These are physical implants, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition based on specimen analysis
- Using reagents or analytical instruments
The APOLLO™ Anterior Cervical Plate (ACP) System is a surgical implant used to provide mechanical support and stabilization to the cervical spine. It is a medical device, but it falls under the category of implantable devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · Spondylolisthesis,
- · Trauma (including fractures or dislocations),
- · Tumors,
- · Deformity (defined as kyphosis, lordosis, or scoliosis),
- · Pseudarthrosis,
- · Failed previous fusion,
- · Spinal stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters, lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
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)
Non-clinical mechanical testing was performed consisting of the following test modes:
- Static and dynamic compression bending per ASTM F1717 .
- Static torsion per ASTM F1717
The results of this non-clinical testing show that the strength of APOLLO™ device is sufficient for its intended use. All data indicates substantial equivalence to the predicate system. Clinical data and conclusions were not needed for this 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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
March 23, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
Aurora Spine, Inc. % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Ave.. Suite 106 Carlsbad. California 92008
Re: K210325
Trade/Device Name: APOLLO™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 31, 2021 Received: February 4, 2021
Dear Jeffrey Brittan:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210325
Device Name
APOLLO™ Anterior Cervical Plate (ACP) System
Indications for Use (Describe)
The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · Spondylolisthesis,
- · Trauma (including fractures or dislocations),
- · Tumors,
- · Deformity (defined as kyphosis, lordosis, or scoliosis),
- · Pseudarthrosis,
- · Failed previous fusion,
- · Spinal stenosis
Type of Use (Select one or both, as applicable) | |
---|---|
> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary: APOLLO™ Anterior Cervical Plate (ACP) System
| Company: | Aurora Spine, Inc.
1930 Palomar Point Way, Suite 103
Carlsbad, CA 92008
(760) 424-2004 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Laszlo Garamszegi
CTO |
| Representative/
Consultant: | Jeffrey Brittan
Watershed Idea Foundry
(714) 287-6780
jeffbrittan@watershedideas.com |
| Date Prepared: | January 25, 2021 |
| Device Name: | APOLLO™ Anterior Cervical Plate (ACP) System |
| Common Name: | Anterior Cervical Plate |
| Classification: | Per 21 CFR as follows:
§888.3060 Spinal intervertebral body fixation orthosis
Product Code: KWQ
Regulatory Class: II
Orthopedic Review Panel |
| Predicate Device: | Synthes Anterior Cervical Locking Plate (ACLP) System
(K031276) – Primary
Osteomed Implantes Anterior Cervical Plate System
(K151553) |
| Reference Device: | Aurora Spine Zip MIS Interspinous Fusion System
Reference Device: (K133091) |
Purpose:
The purpose of this submission is to request clearance for the APOLLO™ Anterior Cervical Plate (ACP) System.
Device Description:
The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters,
4
lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.
Indications for Use:
The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- Spondylolisthesis,
- . Trauma (including fractures or dislocations).
- . Tumors.
- . Deformity (defined as kyphosis, lordosis, or scoliosis),
- . Pseudarthrosis.
- . Failed previous fusion,
- Spinal stenosis .
Technological Characteristics:
The plates and bone screws are manufactured from titanium alloy per ASTM F136, which has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. Plates are offered in multiple levels and lengths, and screws are offered in multiple diameters, lengths, and tip configurations.
Performance Data:
Non-clinical mechanical testing was performed consisting of the following test modes:
- Static and dynamic compression bending per ASTM F1717 .
- . Static torsion per ASTM F1717
The results of this non-clinical testing show that the strength of APOLLO™ device is sufficient for its intended use. All data indicates substantial equivalence to the predicate system. Clinical data and conclusions were not needed for this device.
Basis of Substantial Equivalence:
The APOLLO™ device has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. These systems offer equivalent plate/screw constructs that incorporate a screw locking mechanism. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.