(205 days)
Not Found
No
The summary describes a mechanical spinal implant system and associated instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The focus is on the materials, components, and intended surgical use.
No
The device is a system of implants (rods, hooks, screws) used to stabilize the spine and promote fusion, which falls under the category of surgical implants rather than a therapeutic device that actively treats disease.
No.
The device is a spinal fixation system intended to promote fusion of the cervico-thoracic regions of the spine. It consists of rods, hooks, screws, and other components used to build a spinal construct. It is a surgical implant for treatment, not a device used to identify or determine a disease, injury, or other condition.
No
The device description explicitly lists physical components made of titanium and cobalt chromium (rods, hooks, screws, caps, connectors, instruments, cases), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant system designed to promote fusion and provide stabilization in the cervico-thoracic spine. This is a therapeutic and structural function within the body.
- Device Description: The description details the components of a spinal implant system (rods, hooks, screws, etc.) made from medical-grade materials. These are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:
- Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Spinal Stenosis
- Fracture/ Dislocation
- Deformities or Curvature
- Tumors
- Pseudoarthrosis
- Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNI, MNH
Device Description
The Pioneer Posterior Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial screws, favored angle screws, locking caps, and connecting components used to build a cervico-thoracic spinal construct. The Pioneer Posterior Cervico-Thoracic System components are manufactured from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together. The Pioneer Posterior Cervico-Thoracic System can be attached to Pioneer Quantum® Spinal Rod System using parallel connectors. The 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
Cervico-thoracic regions of the spine (C1-T3), upper thoracic spine (T1-T3)
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)
Testing per recognized ASTM standards was presented.
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.
K070638, K002733, K003780, K032394, K990965
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Pioneer Posterior Cervico-Thoracic System
510(k) Summary
FEB 1 9 2010
| Sponsor: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855
(906) 226-4812
Contact: Emily M. Downs | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------|
| Device Name: | Pioneer Posterior Cervico-Thoracic System | | |
| Classification Name: | Spinal Interlaminal Fixation Orthosis
Pedicle Screw System | | |
| Classification Number: | Product Code/ Regulation Number:
KWP/ 888.3050 - Spinal Interlaminal Fixation Orthosis
MNI/ 888.3070(b)(1)- Pedicle Screw Spinal System
MNH/ 888.3070(b)(1)- Pedicle Screw Spinal System
Panel Code: 87 | | |
| Description: | The Pioneer Posterior Cervico-Thoracic System consists of a variety of
rods, hooks, polyaxial screws, favored angle screws, locking caps, and
connecting components used to build a cervico-thoracic spinal
construct. | | |
| | The Pioneer Posterior Cervico-Thoracic System components are
manufactured from medical grade titanium alloy and medical grade
cobalt chromium. Medical grade titanium alloy and medical grade
cobalt chromium may be used together. | | |
| | The Pioneer Posterior Cervico-Thoracic System can be attached to
Pioneer Quantum® Spinal Rod System using parallel connectors. | | |
| | The system also contains Class 1 manual surgical instruments and cases
that are considered exempt from premarket notification. | | |
| Intended Use: | The Pioneer Posterior Cervico-Thoracic System is indicated to promote
fusion of the cervico- thoracic regions of the spine (C1-T3). The
intended indications are as follows: | | |
| | - Degenerative Disc Disease (as defined by neck or back pain of
discogenic origin with degeneration of the disc confirmed by history
and radiographic studies | | |
| | - Spondylolisthesis | | |
| Pioneer Surgical Technology | | 119 | February 12, 2010 |
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February 12, 2010
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1
| K0922 95 | |
|---|---|
| Pioneer Posterior Cervico-Thoracic System | |
| - Spinal Stenosis | |
| - Fracture/ Dislocation | |
| - Deformities or Curvature | |
| - Tumors | |
| - Pseudoarthrosis | |
| - Revision of previous cervical and upper thoracic spine surgery | |
| The use of the screws is limited to placement in the upper thoracic spine | |
| (T1-T3) in treating thoracic conditions only. The screws are not | |
| intended for use in the cervical spine. | |
| The hooks and rods are also intended to provide stabilization to promote | |
| fusion following reduction of fracture/ dislocation or trauma in the | |
| cervical/ upper thoracic (C1-T3) spine. | |
| Material: | Materials used to manufacture the implants and instruments of this |
| system follow ASTM Standard Specifications. | |
| Performance Data: | Testing per recognized ASTM standards was presented. |
| Performance and SE | |
| Determination: | The characteristics of the Pioneer Posterior Cervico-Thoracic System |
| are similar to the following predicate devices: | |
| 1. Atoll Cervico-Thoracic System (K070638), Theken Spine, SE date | |
| 05/30/2007. | |
| 2. Summit OCT Spinal System (K002733), DePuy AcroMed, Inc., SE | |
| date 12/15/2000. | |
| 3. VERTEXTM Reconstruction System (K003780), Medtronic Sofamor | |
| Danek USA, Inc., SE date 09/28/2001. | |
| 4. Spine Oasys System (K032394), Stryker, SE date 2/20/2004 | |
| 5. Cervifix/ Starlock System (K990965) Synthes (USA), SE date | |
| 7/1/1999. | |
| Equivalence for Pioneer Posterior Cervico-Thoracic System is based on | |
| similarities of intended use, design, and physical characteristics when | |
| compared to predicate devices. Therefore, Pioneer Surgical Technology | |
| believes that there is sufficient evidence to conclude that the Pioneer | |
| Posterior Cervico-Thoracic System is substantially equivalent to | |
| existing legally marketed devices. | |
2002
) a
February 12, 2010
·
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains the department's emblem, which is a stylized representation of a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 9 2010
Pioneer Surgical Technology, Inc. % Ms. Emily M. Downs 375 River Park Circle Marquette, Michigan 49855
Re: K092295
Trade/Device Name: Pioneer Posterior Cervico-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: February 12, 2010 Received: February 16, 2010
Dear Ms. Downs:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Emily M. Downs
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 go to http://www.fda.gov/AboutFDA/CentersOffices/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,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Pioneer Posterior Cervico-Thoracic System
3.0 Indications for Use Statement
K09 2295 510(k) Number (if knówn):
Pioneer Posterior Cervico-Thoracic System Device Name:
Indications:
The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:
- Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis -
- Spinal Stenosis -
- -Fracture/ Dislocation
- -Deformities or Curvature
- -Tumors
- Pseudoarthrosis -
- Revision of previous cervical and upper thoracic spine surgery -
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| Page 1 of 1 |
| Pioneer Surgical Technology Premarket Notification | 510(k) Number: K092295 | Confidential July 27, 2009 |
|---|---|---|
| ---------------------------------------------------- | ------------------------ | ---------------------------- |