The Pallas M Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation 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 turnor and failed previous fusion (pseudarthrosis).

Device Description

The Pallas M Spinal System consists of rods, screws, revision rod system, lilac rod system, MIS pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:

The provided 510(k) submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance testing. Instead, this submission relies on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (2-9) related to a performance study will be marked as "Not Applicable" or "Not Provided" because such a study was not performed for this specific submission as stated in the document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No explicit performance-based acceptance criteria are presented in this 510(k) summary. The basis for clearance is substantial equivalence to a predicate device, not meeting new performance criteria through testing.	No specific device performance data from testing is reported in this 510(k) summary. The submission states: "No additional testing for this 510(k) submission was performed." The substantial equivalence is based on design, materials, indications, intended use, packaging, and labeling being similar to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. No performance testing with a specific test set was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable / Not Provided. No performance testing with expert-established ground truth was conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. No performance testing requiring adjudication was conducted for this 510(k) submission.

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

Not Applicable / Not Provided. This device is a pedicle screw spinal system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.

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

Not Applicable / Not Provided. This device is a pedicle screw spinal system, not an algorithm. No standalone performance evaluation was done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Not Provided. No performance testing requiring ground truth was conducted for this 510(k) submission.

8. The sample size for the training set

Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm requiring a training set.

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

Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm.

Summary of the Study (or lack thereof) to Prove Acceptance:

The Pallas M Spinal System obtained 510(k) clearance by demonstrating substantial equivalence to an existing legally marketed device, the "Pallas M Spinal System (Korea Bone Bank Co., Ltd.; K102574)".

The key points from the submission are:

No additional testing was performed for this 510(k) submission. The device's safety and effectiveness were concluded by comparing its design, materials, indications for use, intended use, packaging, labeling, and performance to the predicate device.
The difference between the subject device and the predicate device is limited to the addition of curved rods and new surgical instruments. The submission implies these minor differences do not alter the fundamental safety and effectiveness profile such that new performance testing would be required.
The FDA's clearance is based on the determination that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the legally marketed device to which it is compared. This is a common pathway for medical device clearances where new performance data specific to the device being submitted is not always required if equivalence to an already cleared device can be sufficiently demonstrated.

Summary

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KI20538

MAR 2 3 2012

12. 510(k) Summary

Submission information:

Submitter: Song Yi Kim Korea Bone Bank Co., Ltd 402, 408-411, Acetechnotower 9th, 345-30, Gasandong, Keumcheongu, Seoul, South Korea Tel: 82-02-2014-0475 Fax: 82-02-2104-0478

Official Correspondent: Kodent Inc. April Lee 325 N. Puente st. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116

Date prepared: 3/22/2012

Device Information:

Trade Name:	Pallas M Spinal System
Common Name:	edicle Screw Spinal Fixation System
Classification Name:	Spinal Pedicle FixationSpondylolisthesis Spinal Fixation
Product Code:	MNH, MNI
Regulation Number:	21 CFR 888.3070

General Description:

Indication for Use:

Materials:

The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards.

Performance Data:

No additional testing for this 510(k) submission was performed.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

Pallas M Spinal System (Korea Bone Bank Co., Ltd.; K102574)

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Comparison to Predicate Devices:

Comparisons have established that the subject of Pallas M Spinal System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate device of the type currently marketed in the U.S.

The difference between the subject device and the predicate device is the addition of curved rods and new surgical instruments.

Conclusion:

Based on the information provided in this premarket notification, Korea Bone Bank Co., Ltd . concludes that The Pallas M Spinal System is safe, effective and substantially equivalent to the predicate devices as described herein,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract emblem, possibly representing a stylized bird or a symbol of health and human services. The image is in black and white.

Public Health Service

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

MAR 2 3 2012

Korea Bone Bank Co., Ltd. % Ms. April Lee Kodent, Inc. 325 N. Puente St., Unit B Brea, California 92821

Re: K120538

Trade/Device Name: Pallas M Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: February 22, 2012 Received: February 22, 2012

Dear Ms. Lee:

We have reviewed vour 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

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Page 2 - Ms. April Lee

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.

E.I. Keith

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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Indication for Use

1120538

510(K) Number (if known):

Device Name: Pallas M Spinal System

Indication for Use:

Prescription Use

AND/OR

Over-The-Counter

(Per 21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Division Sign-Of Vision of Surgical, Orthopedic, nd Restorative Devices

KITO 238 510(k) Number_

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.