(254 days)
Medtronic Sofamor Danek Spinal Mesh, Hedrocel Vertebral Body Replacement, DePuv Acromed VBR System, Synthes Vertebral Spacer System, Scient'x Ellys and Aurys VBR, DePuy Acromed Surgical Titanium Mesh System, DePuy Acromed Stackable Cage System, EBI lonic Spine Spacer System, Medtronic Sofamor Danek VERTE-STACK Spinal System
Not Found
No
The summary describes a physical implant (spinal system) and its intended use for surgical correction and stabilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device replaces anatomical structures and restores biomechanical integrity, which are mechanical functions rather than therapeutic in the sense of treating a disease or condition therapeutically. It aids in surgical correction and stabilization, acting as a structural support.
No
The device is a spinal implant intended for vertebral body replacement and stabilization, which is a therapeutic function rather than a diagnostic one. Its purpose is to physically restore height and biomechanical integrity, not to identify or characterize medical conditions.
No
The device description explicitly states the ARX Spinal System is a physical implant manufactured from a ceramic material, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ARX Spinal System is described as a surgically implanted device made of ceramic material that acts as a spacer to maintain vertebral body spacing and angulation. It is used to replace or restore height of a damaged vertebral body.
- Intended Use: The intended use is for surgical correction and stabilization of the spine by replacing vertebral bodies. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
The description clearly indicates a surgically implanted medical device used for structural support and stabilization within the body, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The ARX Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The ARX Spinal System is always to be used with supplemental internal spinal fixation. Additionally, the ARX Spinal System may be used with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The ARX Spinal System acts as a spacer to maintain proper vertebral body spacing and anqulation following a partial or total corpectorny. The device is surgically implanted between vertebral bodies from an anterior, anterior-lateral, or lateral surgical approach. The ARX Spinal System is manufactured from MC2, a ceramic material. The ARX Spinal System is for single level anterior spinal use from T1 to L5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
Not Found
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)
Not Found
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.
Medtronic Sofamor Danek Spinal Mesh, Hedrocel Vertebral Body Replacement, DePuv Acromed VBR System, Synthes Vertebral Spacer System, Scient'x Ellys and Aurys VBR, DePuy Acromed Surgical Titanium Mesh System, DePuy Acromed Stackable Cage System, EBI lonic Spine Spacer System, Medtronic Sofamor Danek VERTE-STACK Spinal System
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
§ 888.3060 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
Image /page/0/Picture/2 description: The image shows a series of handwritten alphanumeric characters. The characters appear to be 'K 051525 000256'. The characters are written in a dark ink on a white background.
510(k) SUMMARY
| SPONSOR NAME: | Amedica Corp.
615 Arapeen Drive
Suite 302
Salt Lake City, Utah 84108 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (801) 583-5100
E-Mail: Robert@AmedicaCorp.com |
| TRADE NAME: | Arx™ Spinal System |
| COMMON NAME: | Ceramic Bone Fixation Appliance |
| CLASSIFICATION: | Spinal Intervertebral Body Fixation Orthosis (Product Code 87
MQP) are Class II per 21 CFR §888.3060, reviewed by the
Orthopedic Devices panel. |
PREDICATE DEVICES:
- Medtronic Sofamor Danek Spinal Mesh
- · Hedrocel Vertebral Body Replacement
- · DePuv Acromed VBR System
- · Synthes Vertebral Spacer System
- · Scient'x Ellys and Aurys VBR
- · DePuy Acromed Surgical Titanium Mesh System
- · DePuy Acromed Stackable Cage System
- · EBI lonic Spine Spacer System
- · Medtronic Sofamor Danek VERTE-STACK Spinal System
DEVICE DESCRIPTION:
The ARX Spinal System acts as a spacer to maintain proper vertebral body spacing and anqulation following a partial or total corpectorny. The device is surgically implanted between vertebral bodies from an anterior, anterior-lateral, or lateral surgical approach. The ARX Spinal System is manufactured from MC2, a ceramic material. The ARX Spinal System is for single level anterior spinal use from T1 to L5.
INTENDED USE:
The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The ARX Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The ARX Spinal System is always to be used with supplemental internal spinal fixation. Additionally, the ARX Spinal System may be used with bone graft.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests, design comparisons, and functional analyses conducted on the Arx Spinal System demonstrate that it is substantially equivalent to the predicate devices.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines extending from its head.
FEB 1 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert M. Wolfarth Mr. Robert M. Wolfairs and Quality Assurance Amedica Corporation 615 Arapeen Drive, Suite 302 Salt Lake City, Utah 84108
Re: K051525
R091525 Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 30, 2006 Received: January 31, 2006
Dear Mr. Wolfarth:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(K) premained in substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally mancede proure Americal Device Ameridments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chactinence with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with provey at application (P devices that have been reciassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require upprovide of the general controls provisions of the Act. The .
You may, therefore, market the device, subject to the generation, You may, therefore, market the device, subject to the gentificalism listing of the space and general controls provisions of the Fectivers of there and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis exiting major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controlls. Little 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Regening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a substance requirements of the Act
that FDA has made a determination that your device complies. You must that IDA has made a decernmanon that your do rees. by other Federal agencies . You must a or any Federal statutes and regulations administered of each and listing (21)
comply with all the Act's requirements, including, but not limited to: registration and list comply with all the Act s requirements, mercesses and manufacturing practice requirements as schoolsests of CFR Part 807); labentig (21 CFR 1 all 601); god manari 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. Wolfarth
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin narkemig your antial equivalence of your device to a legally premarket notification. THE FDA mining of sabstantial of 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 If you desire specific advice for your ac not 2010 - 12:00 please note the regulation entitled, Conlact the Office of Complaned at (210) =16 ================================================================================================================================= "Misbranding by reletence to premance nouthead.com the Act from the Division of Small other general Information on your responsionnes and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Pisobanco around collectivindustry/support/index.html.
Sincerely yours,
Herbert Lemmer
Mark N. Molkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KOS IS 2S
Device Name: Arx™ Spinal System
Indications for Usc:
The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction The ARX Spinal System is Intended for vertebrar body replacement the thoracolumbar spine (TT to
and stabilization of the spine. The device is indicated for use in the thorac and stablization of the spine. The device is thatsated, or unstable vertebral body of L5) to replace or restore neight a collapsed, damaged, dissurature). It is indicated to achieve in portion thereof, excised as a result of tamer of trainer of trainer the height of a collapsed or damaged vertebral body.
The ARX Spinal System is designed to restore the biomechanical integrity of the anterior, The ARA Spirial System's designed to rocers the tro the crombon for a prolonged period.
The ARX Spinal System is always to be used with supplemental internal spinal fixation. The ARX Spinal System may be used with bone graft.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Huth Lunto
(Divisi Division of General, Restorative, and Neurological Devices
Page of
(Posted November 13, 2003)
510(k) Number ________________________________________________________________________________________________________________________________________________________________