(71 days)
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No
The device description focuses solely on the mechanical components (plates and screws) and their material and design, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the treatment of various medical conditions such as Degenerative Disc Disease (DDD), spondylolisthesis, trauma, spinal stenosis, and tumors, which signifies its therapeutic purpose.
No
The device is described as an anterior screw fixation system (plates and screws) for the cervical spine, used in surgical procedures. It is an implant, not a tool for diagnosing conditions.
No
The device description explicitly states it is composed of plates and screws made from titanium alloy, which are hardware components.
No, 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 ACLP System is a surgical implant (plates and screws) used for anterior screw fixation to the cervical spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use describes a surgical procedure to stabilize the cervical spine for various conditions. It does not involve analyzing biological samples.
Therefore, based on the provided information, the ACLP System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis and scoliosis).
Product codes
KWQ
Device Description
The ACLP System is an addition to Synthes' existing Anterior Cervical Vertebrae Plate System (Anterior CSLP). The ACLP System is composed of plates and screws which are made from titanium allov Ti-6Al-7Nb (ASTM F1295). These plates attach to the anterior cervical spine with a minimum of four screws per plate.
The plates range in length to accommodate one, two, three, and four level procedures. The plates in the system are pre-lordosed to accommodate the cervical spine minimizing the need for the surgeon to manually bend the plates.
The screws in the ACLP System are 4.0mm and 4.5mm conical head screws. They are self-drilling and self-tapping in both cancellous and cortical thread profiles and are available in lengths ranging from 12mm to 16mm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
JUL 2 2003
11.0 510(K) SUMMARY
DESCRIPTION
The ACLP System is an addition to Synthes' existing Anterior Cervical Vertebrae Plate System (Anterior CSLP). The ACLP System is composed of plates and screws which are made from titanium allov Ti-6Al-7Nb (ASTM F1295). These plates attach to the anterior cervical spine with a minimum of four screws per plate.
The plates range in length to accommodate one, two, three, and four level procedures. The plates in the system are pre-lordosed to accommodate the cervical spine minimizing the need for the surgeon to manually bend the plates.
The screws in the ACLP System are 4.0mm and 4.5mm conical head screws. They are self-drilling and self-tapping in both cancellous and cortical thread profiles and are available in lengths ranging from 12mm to 16mm.
INDICATIONS
The ACLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis and scoliosis).
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 JUL
Mr. Jonathan Gilbert Project Manager, Regulatory Affairs SYNTHES Spine 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K031276
Trade Name: Synthes Anterior Cervical Locking Plate (ACLP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 21, 2003 Received: April 25, 2003
Dear Mr. Gilbert:
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.
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.
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Page 2 - Mr. Jonathan Gilbert
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
fo Mark M. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3.0 INDICATIONS FOR USE FORM
510(k) Number (if known): K031276
Device Name: Synthes Anterior Cervical Locking Plate (ACLP) System
INDICATIONS FOR USE:
The ACLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis and scoliosis).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109)
OR Over-The-Counter Use
Mark A. Millman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031276
CONFIDENTIAL