(119 days)
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML, image processing, or data sets for training/testing algorithms.
Yes
The device is intended to immobilize spinal segments and assist with fusion in patients with various spinal instabilities or deformities, which are therapeutic actions.
No
The provided text describes the DPZ Pedicular Fixation System as a device for immobilization and stabilization of spinal segments as an adjunct to fusion. This is an active treatment, not a diagnostic process.
No
The device description explicitly states it is a "multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links," which are physical hardware components.
Based on the provided information, the DPZ Pedicular Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to provide immobilization and fixation of spinal segments. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device components (pedicle screws, rods, cross links) are physical implants designed to be surgically placed within the spine. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the DPZ Pedicular Fixation System is a surgical implant, specifically a spinal fixation system, and not an IVD.
N/A
Intended Use / Indications for Use
The DPZ Pedicular Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
Product codes
MNI, MNH
Device Description
The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 analyses were conducted: Static and dynamic compression per ASTM F1717 Static torsion per ASTM F1717 The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Xia Spinal System - Stryker (K071373 / K113666)
Reference Device(s)
ZODIAC™ Polyaxial Spinal Fixation System - Alphatec (K042673/ K071890 / K093077/K100685), Synergy VLS - open - Cross Medical (K940631 / K950099), Moss Miami SS - DePuy Spine (K000536), PWB (now Synergy) - Cross Medical (K920116), Polyaxial LP - Scient'x (K062912), FixxSure Crosslink (K081331), Synthes Matrix (K092929)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Osteomed Implantes, LTDA % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K150294
Trade/Device Name: DPZ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: May 4, 2015 Received: May 6, 2015
Dear Mr. Webb:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. J.D. Webb
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" (21 CFR 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 vours.
Mark N. Melkerson -S
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) K150294
Device Name DPZ Pedicular Fixation System
Indications for Use (Describe)
The DPZ Pedicular Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
| 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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| Date Prepared | May 4, 2015 |
|---|---|
| Submitted By | Osteomed Implantes, LTDA |
| Washington Luiz Road, km 172 | |
| Condomínio Conpark - Rua 6, S/N | |
| CEP 13501-600 | |
| Rio Claro - SP | |
| BRAZIL | |
| (19) 3532-3411 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | DPZ Pedicular Fixation System |
| Common Name | pedicle screw system |
| Classification Name | orthosis, spinal pedicle fixation |
| orthosis, spondylolisthesis spinal fixation | |
| Class | II |
| Product Code | MNI |
| MNH | |
| CFR Section | 21 CFR section 888.3070 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Xia Spinal System - Stryker (K071373 / K113666) |
| Reference Predicate | |
| Devices | ZODIAC™ Polyaxial Spinal Fixation System - Alphatec (K042673/ K071890 / |
| K093077/K100685) | |
| Synergy VLS - open - Cross Medical (K940631 / K950099) | |
| Moss Miami SS - DePuy Spine (K000536) | |
| PWB (now Synergy) - Cross Medical (K920116) | |
| Polyaxial LP - Scient'x (K062912) | |
| FixxSure Crosslink (K081331) | |
| Synthes Matrix (K092929) | |
| Device Description | The DPZ Pedicular Fixation System is a top loading, multiple component, |
| posterior spinal fixation system which consists of pedicle screws, rods and cross | |
| links. All of the components are available in a variety of sizes to more closely | |
| match the patient's anatomy. | |
| Materials | Titanium alloy (Ti6Al4V) conforming to ASTM F136 |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The DPZ Pedicular Fixation System is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety, and | |
| performances. | |
| Indications for Use | The DPZ Pedicular Fixation System is intended to provide immobilization and |
| stabilization of spinal segments in skeletally mature patients as an adjunct to | |
| fusion in the treatment of the following acute and chronic instabilities o | |
| deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis | |
| with objective evidence of neurological impairment, fracture, dislocation, | |
| deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, | |
| pseudarthrosis and failed previous fusion. | |
| The DPZ Pedicular Fixation System is also intended for non-cervical pedicle | |
| screw fixation for the following indications: severe spondylolisthesis (grades 3 | |
| and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by | |
| autogenous bone graft having implants attached to the lumbar and sacral spine | |
| (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. | |
| It is also intended for the following indications: trauma (i.e. fracture o | |
| dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, | |
| and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Static and dynamic compression per ASTM F1717 Static torsion per ASTM F1717 The results of these evaluations indicate that the DPZ Pedicular Fixation | |
| System is equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Osteomed Implantes considers the DPZ Pedicular Fixation System to be |
| equivalent to the predicate device listed above. This conclusion is based upon | |
| the device's similarities in principles of operation, technology, materials, and | |
| indications for use |
510(k) Summary: DPZ Pedicular Fixation System
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