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.

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.

AI/ML Overview

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance (Result Summary)
Static compression per ASTM F1717	"The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices."
Dynamic compression per ASTM F1717	"The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices."
Static torsion per ASTM F1717	"The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

Not applicable, as this refers to human reader review and consensus, which was not performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done, as "No clinical studies were performed."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

9. How the ground truth for the training set was established:

Not applicable for the same reason as above.

Summary

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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)

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, LTDAWashington Luiz Road, km 172Condomínio Conpark - Rua 6, S/NCEP 13501-600Rio Claro - SPBRAZIL(19) 3532-3411 Tele
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	DPZ Pedicular Fixation System
Common Name	pedicle screw system
Classification Name	orthosis, spinal pedicle fixationorthosis, spondylolisthesis spinal fixation
Class	II
Product Code	MNIMNH
CFR Section	21 CFR section 888.3070
Device Panel	Orthopedic
Primary PredicateDevice	Xia Spinal System - Stryker (K071373 / K113666)
Reference PredicateDevices	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 crosslinks. All of the components are available in a variety of sizes to more closelymatch the patient's anatomy.
Materials	Titanium alloy (Ti6Al4V) conforming to ASTM F136
SubstantialEquivalence Claimedto Predicate Devices	The DPZ Pedicular Fixation System is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety, andperformances.
Indications for Use	The DPZ Pedicular Fixation System is intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunct tofusion in the treatment of the following acute and chronic instabilities odeformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesiswith 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 pediclescrew fixation for the following indications: severe spondylolisthesis (grades 3and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion byautogenous 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 odislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis,and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
Non-clinical TestSummary	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 FixationSystem 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 beequivalent to the predicate device listed above. This conclusion is based uponthe device's similarities in principles of operation, technology, materials, andindications for use

510(k) Summary: DPZ Pedicular Fixation System

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Regulation Number and Section

N/A