(63 days)
Not Found
No
The summary describes a mechanical implant system for spinal stabilization and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for stabilization of the cervical spine due to various instabilities (e.g., trauma, deformity, tumor, degenerative disc disease), which are conditions requiring therapeutic intervention to restore stability and function.
No
The device description indicates it is an implantable system for spinal stabilization, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of implantable titanium alloy plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The DePuy Pulse Anterior Cervical Plate System is an implantable device (plates and screws) used for stabilizing the cervical spine during surgery. It is physically placed within the body.
- Intended Use: The intended use is for surgical stabilization of the cervical spine, not for analyzing biological samples.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
Product codes
KWQ
Device Description
The DePuy Pulse Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The DePuy Pulse Anterior Cervical Plate System consists of an assortment of implantable titanium alloy plates and screws in various sizes.
The DePuy Pulse Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2 to T1
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
Non-clinical Test Summary: The following mechanical tests were conducted: Static compression bending testing in accordance with ASTM F-1717 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode. The acceptance criteria was/were met. Static torsion testing in accordance with ASTM F-1717 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode. The acceptance criteria was/were met. Dynamic compression bending testing in accordance with ASTM F-1717 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode. The acceptance criteria was/were met.
Clinical Test Summary: No clinical tests were performed.
Key Metrics
Not Found
Predicate Device(s)
Skyline Anterior Cervical Plate System - K103491, Slim-Loc Anterior Cervical Plate System - K013877, Uniplate Anterior Cervical Plate System - K082273
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K112724
page 1 of 2
510(K) SUMMARY
| Submitter: | Medos Internation Sàrl
Chemin-Blanc 38
Le Locle, CH-NE 2400, Switzerland |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eugene Bang
Regulatory Affairs Associate
DePuy Spine, Inc.
Voice: (508) 977-3966
Fax: (508) 828-3797 |
| Date Prepared: | September 16, 2011 |
| Trade Name: | DePuy Pulse Anterior Cervical Plate System |
| Device Class: | Class II |
| Product Code(s): | KWQ |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulation Number: | 888.3060 |
| Predicate Devices: | Skyline Anterior Cervical Plate System - K103491
Slim-Loc Anterior Cervical Plate System - K013877
Uniplate Anterior Cervical Plate System - K082273 |
| Device Description: | The DePuy Pulse Anterior Cervical Plate System is intended for
anterior screw fixation of the plate to the cervical spine. The fixation
construct consists of a cervical plate that is attached to the vertebral body
of the cervical spine with self-tapping bone screws using an anterior
approach. The DePuy Pulse Anterior Cervical Plate System consists of
an assortment of implantable titanium alloy plates and screws in various
sizes.
The DePuy Pulse Anterior Cervical Plate System also contains Class 1
manual surgical instruments and cases that are considered exempt from
premarket notification. |
| Indications: | The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of
the cervical spine from C2 to T1 employing unicortical screw fixation at the
anterior face of the vertebral bodies. Specific clinical indications for anterior
plating include: instability caused by trauma; instability associated with
correction of cervical lordosis and kyphosis deformity; instability associated with
pseudoarthrosis as a result of previously failed cervical spine surgery; instability
associated with major reconstructive surgery for primary tumors or metastatic
malignant tumors of the cervical spine; instability associated with single or
multiple level corpectomy in advanced degenerative disc disease, spinal canal
stenosis and cervical myelopathy. |
| Materials: | Manufactured from ASTM F-136 implant grade titanium alloy. |
| Comparison to
Predicate Device: | The substantial equivalence of the subject device to the predicates indentified
above is based upon the equivalence of intended use, design (fundamental
scientific technology), materials, manufacturing methods, performance, sterility,
biocompatibility, safety and packaging design. |
| Non-clinical Test
Summary: | The following mechanical tests were conducted:
Static compression bending testing in accordance with ASTM F-1717
Standard Test Method for Spinal Implant Constructs in a Vertebrectomy
Mode The acceptance criteria was/were met. Static torsion testing in accordance with ASTM F-1717 Standard Test
Method for Spinal Implant Constructs in a Vertebrectomy Mode . The
acceptance criteria was/were met. Dynamic compression bending testing in accordance with ASTM F-1717
Standard Test Method for Spinal Implant Constructs in a Vertebrectomy
Mode . The acceptance criteria was/were met. |
| Clinical Test
Summary: | No clinical tests were performed. |
| Conclusion: | Based on the predicate comparison and testing, the subject device DePuy Pulse
Anterior Cervical Plate System is substantially equivalent to the predicate
devices. |
·
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 1 2011
Medos International, Sarl % DePuy Spine, Inc. Mr. Eugene Bang 325 Paramount Drive Raynham, Massachusetts 02767
Re: K112724
Trade/Device Name: DePuy Pulse Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: September 16, 2011 Received: September 19, 2011
Dear Mr. Bang:
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
3
Page 2 - Mr. Eugene Bang
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
for Poffro
N.A
N.A
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number: K112724
Device Name: DePuy Pulse Anterior Cervical Plate System
Indications For Use:
The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII2724 510(k) Number_