(106 days)
No
The summary describes a physical implant (cervical cage) and its mechanical properties and testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for use in cervical interbody fusion procedures to treat degenerative disc disease, which involves addressing a medical condition.
No
This device is an implantable medical device (cervical cage) used for interbody fusion procedures, not for diagnosing conditions.
No
The device description clearly details a physical implant made of PEEK and titanium alloy, intended for surgical implantation. The performance studies also focus on mechanical testing of the physical device.
Based on the provided information, the Stryker Spine AERO®-C Cervical Cage is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the AERO®-C Cervical Cage is an implantable device used in surgical procedures (cervical interbody fusion) to treat degenerative disc disease. It is a physical cage designed to be placed within the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, perform tests on specimens, or provide diagnostic information based on such analysis.
Therefore, the AERO®-C Cervical Cage is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The AERO®-C Cervical Cage is a hollow, ring-shaped PEEK Optima (per ASTM F2026) cage surrounded by a titanium alloy (per ASTM F136 and ISO 5832-3) jacket. It is intended for use as an interbody fusion device and is offered in a variety of heights, widths, depths, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used with the internal supplemental fixation provided (AERO®-C Fixation Anchors). The AERO®-C Fixation Anchors are constructed from titanium alloy and possess rails that mate with dovetail channels located within the AERO®-C Cervical Cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-C3 disc, C7-T1 disc
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)
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AERO-C® implant system and demonstrated substantially equivalent performance to the identified predicate device systems.
The following mechanical tests were performed:
• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Static Torsion (per ASTM F2077)
• Dynamic Torsion (per ASTM F2077)
• Expulsion (per ASTM F04-25-02-02 Draft)
• Subsidence (per ASTM F2267)
• Wear Debris Assessment
• Fixation Anchor Engagement Evaluation
• Dynamic Cadaveric Testing involving the implantation of the AERO®-C device into multiple functional spinal units and subsequent evaluation of fatigue performance under multiple loading modes.
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.
Stryker Spine AVS® AS PEEK Spacer, K142251, K120486, Stryker Spine AVS® Anchor-C Cervical Cage System, K102606, ORTHOVITA PEEK Cages, K072981, Surgicraft STALIF C®, K150053, Synthes Zero-P, K072981, LDR Spine ROI-C System, K091088
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.
Stryker Spine AERO® -AL Lumber Cage System, K133328, Stryker Spine AERO®-LL Lumbar Cage System, K142066
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Stryker Spine Ms. Sorava King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K152532
Trade/Device Name: AERO®-C Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: November 23, 2015 Received: November 24, 2015
Dear Ms. King:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please 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 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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152532
Device Name AERO®-C Cervical Cage System
Indications for Use (Describe)
The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
| 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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| Section 10: 510k Summary | ||
|---|---|---|
| 510(k) Summary: AERO®- C Cervical Cage System | ||
| Submitter: | Stryker Spine | |
| 2 Pearl Court | ||
| Allendale, New Jersey 07401 | ||
| Contact Person | Soraya King | |
| Regulatory Affairs Specialist | ||
| Phone: 201-749-8296 | ||
| Fax: 201-962-4296 | ||
| Email: Soraya.King@Stryker.com | ||
| Date Prepared | November 23, 2015 | |
| Trade Name | AERO®-C Cervical Cage System | |
| Proposed Class | Class II | |
| Classification Name | ||
| and Number | Intervertebral body fusion device, 21 CFR 888.3080 | |
| Product Code | ODP | |
| Predicate Devices | The AERO-C® Cervical Cage System was shown to be | |
| substantially equivalent to the devices listed below: | ||
| Primary Predicate | ||
| • Stryker Spine AVS® AS PEEK Spacer, K142251 & | ||
| K120486 | ||
| Additional Predicates | ||
| • Stryker Spine AVS® Anchor-C Cervical Cage System, | ||
| K102606 | ||
| • ORTHOVITA PEEK Cages, K072981 | ||
| • Surgicraft STALIF C®, K150053 | ||
| • Synthes Zero-P, K072981 | ||
| • LDR Spine ROI-C System, K091088 | ||
| Reference Devices | ||
| 510(k) Summary: AERO®- C Cervical Cage System | ||
| Stryker Spine AERO® -AL Lumber Cage System, K133328 Stryker Spine AERO®-LL Lumbar Cage System, K142066 | ||
| Device Description | The AERO®-C Cervical Cage is a hollow, ring-shaped PEEK | |
| Optima (per ASTM F2026) cage surrounded by a titanium alloy | ||
| (per ASTM F136 and ISO 5832-3) jacket. It is intended for use | ||
| as an interbody fusion device and is offered in a variety of | ||
| heights, widths, depths, and lordotic angles to adapt to varying | ||
| patient anatomies. The PEEK Optima cage portion consists of | ||
| two closed pockets for graft containment and has serrations on | ||
| the superior and inferior surfaces of the cage. The implant is | ||
| designed to be used with the internal supplemental fixation | ||
| provided (AERO®-C Fixation Anchors). The AERO®-C | ||
| Fixation Anchors are constructed from titanium alloy and | ||
| possess rails that mate with dovetail channels located within the | ||
| AERO®-C Cervical Cage. Once fully seated into the channels, | ||
| the anchors are designed to lock into the titanium jacket. | ||
| Indications for Use | The Stryker Spine AERO®-C Cervical Cage is indicated for use | |
| in cervical interbody fusion procedures in skeletally mature | ||
| patients with degenerative disc disease (DDD) at one level from | ||
| the C2-C3 disc to the C7-T1 disc. |
DDD is defined as neck pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic
studies. These patients should be skeletally mature and have six
weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with
autogenous bone graft and/or allogenic bone graft comprised of
cancellous and/or corticocancellous bone graft, and is to be
implanted via an open, anterior approach. | |
| 510(k) Summary: AERO®- C Cervical Cage System | | |
| | The AERO®-C Cervical Cage System is intended to be used
with supplemental spinal fixation systems that have been cleared
for use in the cervical spine. In addition, the device must be used
with the included fixation anchors. | |
| Summary of the
Technological
Characteristics | The subject AERO-C® implant system and the predicates share
similar design features:
Graft windows for packing autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft Serrations on the superior and inferior surfaces Comparable heights, widths, depths, and lordotic angles Manufactured from PEEK and Titanium Alloy | |
| 510(k) Summary: AERO®- C Cervical Cage System | | |
| Summary of Non-Clinical Testing | Testing in compliance with FDA's June 12, 2007 "Class II
Special Controls Guidance Document: Intervertebral Body
Fusion Device" was performed for the AERO-C® implant
system and demonstrated substantially equivalent performance
to the identified predicate device systems.
The following mechanical tests were performed:
• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Static Torsion (per ASTM F2077)
• Dynamic Torsion (per ASTM F2077)
• Expulsion (per ASTM F04-25-02-02 Draft)
• Subsidence (per ASTM F2267)
• Wear Debris Assessment
• Fixation Anchor Engagement Evaluation
• Dynamic Cadaveric Testing involving the implantation of the
AERO®-C device into multiple functional spinal units and
subsequent evaluation of fatigue performance under multiple
loading modes. | |
| Conclusion | Based upon a comparison of the design features, indications for
use, technological characteristics, the use of established well-
known materials, and mechanical performance, the AERO®-C
Cervical Cage System has demonstrated substantial equivalence
to the identified predicate device systems. | |
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