The MOSS® MIAMI Spine System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS® MIAMI Spine Systems is also indicated for pedicle screw fixation for the treatment of 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.

The MOSS® MIAMI Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MOSS® MIAM! Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The EXPEDIUM® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM® Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The Moss® Miami and Expedium® Spine Systems consists of rods, hooks, pedicle screws, and other components. A subset of the Moss Miami and Expedium systems, which is the basis of this submission, includes titanium pedicle screws and rods that are now sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain pedicle screws and rods will be packaged in sterile multi-packs for customer convenience.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or diagnostic ability.

Instead, the document is a 510(k) summary for a medical device (Moss® Miami and Expedium® Spine Systems) that describes a change in sterilization method (from non-sterile to terminally sterilized via gamma radiation). The key aspect of this submission is demonstrating substantial equivalence to predicate devices.

Here's a breakdown of why the requested information isn't present in this document:

"Acceptance criteria and the reported device performance": This document does not outline numerical performance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). The "performance" being discussed is the effect of the new sterilization method.
"Study that proves the device meets the acceptance criteria": There isn't a clinical or analytical performance study in this document that would measure diagnostic accuracy or similar metrics. The focus is on demonstrating that the sterilization change does not alter the fundamental characteristics or safety/effectiveness of the device compared to its non-sterile predecessors.
"Sample size used for the test set and the data provenance": Not applicable, as there's no diagnostic test set being evaluated.
"Number of experts used to establish the ground truth... and qualifications": Not applicable.
"Adjudication method": Not applicable.
"Multi reader multi case (MRMC) comparative effectiveness study": Not applicable. Such studies are typically for diagnostic imaging devices or AI-powered algorithms where human reader performance is a key metric.
"Standalone (i.e. algorithm only without human-in-the-loop performance) was done": Not applicable, as this device (spinal fixation system) is not an algorithm.
"Type of ground truth used": Not applicable.
"Sample size for the training set": Not applicable.
"How the ground truth for the training set was established": Not applicable.

What the document does state regarding the "study" for acceptance:

The document explains that the sterilization process itself was conducted in compliance with a standard:

Study described: The gamma sterilization is performed in compliance with ISO 11137:2006 (VDMax method).
"Acceptance Criteria" implicitly met: By complying with ISO 11137:2006, the device is accepted to achieve a predefined sterility assurance level (SAL), which is the primary "acceptance criterion" for the sterilization process. The "performance" is that the device is now terminally sterilized to this recognized standard.

Conclusion from the document:

The final conclusion is that the "Substantial Equivalence Justification demonstrates that the device is as safe, as effective, and performs as well as the predicate device." This means the change in sterilization method did not negatively impact the device's safety, effectiveness, or performance, which were already established for the predicate devices.

Summary

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510(K) SUMMARY
A.	Submitter Information
	DePuy Spine, Inc.
	325 Paramount Drive
	Raynham, MA 02767
Contact Person:	Kevin G. Stevens
	Regulatory Affairs Project Manager
Voice:	(508) 977-6445
Fax:	(508) 828-3797
E-Mail:	ksteven1@its.jnj.com
B.	Date Prepared
	February 15, 2011
C.	Device Name

Trade/Proprietary Name:	Moss® Miami and Expedium® Spine Systems
Common/Usual Name:	Spinal System
Classification Name:	Spinal interlaminar fixation orthosis per 21 CFR §888.3050Product code KWP
	Spinal intervertebral body fixation orthosis per 21 CFR §888.3060Product code KWQ
	Pedicle screw spinal fixation per 21 CFR §888.3070Product code NKB, MNI, MNH
Classification	Class III
D.	Predicate Device Name

Trade name: DePuy Spine Expedium® Spine System (K033901) DePuy Spine Moss® Miami Spine System (K955348)

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E. Device Description

F. Intended Use

Moss® Miami System:

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K103490

deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

Expedium® Spine System:

G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The proposed devices are identical to the predicate devices except that the proposed devices will be terminally sterilized by DePuy Spine via gamma radiation. The gamma sterilization is performed in compliance with ISO 11137:2006 (VDMax method). The design, materials, indications, and technology remain identical to the predicate systems.

H. Materials

Manufactured from ASTM F-136 implant grade titanium alloy.

1. Biocompatibility

There have been no changes to the material as a result of the modification. Therefore no new biocompatibility testing has been submitted to support this submission.

J. Conclusion

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lo349o

The Substantial Equivalence Justification demonstrates that the device is as safe, as effective, and performs as well as the predicate device

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・.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Johnson and Johnson % DePuy Spine, Inc. Mr. Kevin G. Stevens Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767

Re: K103490

Trade/Device Name: Moss Miami Spine System Expedium Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: January 14, 2011 Received: January 18, 2011

Dear Mr. Stevens:

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.

FEB 1 7 2011

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Page 2 - Mr. Kevin G. Stevens

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 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/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,

AS vs. Rh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K103490 Device Name: Moss Miami Spine System Indications For Use:

The MOSS MIAMI Spine System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS MIAMI Spine Systems is also indicated for pedicle screw fixation for the treatment of 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.

The MOSS MIAMI Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sigs Beelbal for RRT

rgical, Orthopedic, Restorative Devices

Page 1 of 1

510(k) Number K103490

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K103490

Device Name: Expedium Spine System

Indications For Use:

The EXPEDIUM Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Star Beckhold for RPT

ivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K 103490 510(k) Number.

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Regulation Number and Section

§ 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.