K Number

Device Name

MEDINAUT KYPHOPLASTY SYSTEM

Manufacturer

IMEDICOM

Date Cleared

2014-04-04

(126 days)

Product Code

NDN HRX

Regulation Number

888.3027

Intended Use

The MEDINAUT Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

The MEDINAUT Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body it facilitate the insertion of bone cement through the use of the cement dispensing plunger. The benefits of MEDINAUT Kyphoplasty System are the reduction in back pain and increase of patient's functional abilities, allowing a return to the previous level of activity. It consists of Balloon Catheter, Bone Expander Syringe, Needle Pipe, Needle Pin, Wire Pin (Troca Type, Round Type), Cannula, Expander, Spacer, Cement Pusher, Cement Filler, and Guide Wire. It is supplied sterile and for single disposable use. The MEDINAUT Kyphoplasty System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The system is substantially equivalent in design, function and intended use to the predicate devices.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K041454, K010246, K981251

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical system for kyphoplasty and explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

Yes
The device is intended for the "reduction and fixation of fractures" and aims to reduce back pain and increase patient functional abilities, indicating a therapeutic purpose.

Diagnostic

Explanation: The device is a surgical system used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. It is a treatment device, not a diagnostic one, as it does not diagnose a condition but rather treats it.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components (Balloon Catheter, Bone Expander Syringe, Needle Pipe, etc.) and describes a physical system used in a surgical procedure.

IVD (In Vitro Diagnostic)

Based on the provided information, the MEDINAUT Kyphoplasty System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, specifically during percutaneous vertebral augmentation (kyphoplasty). This is a surgical procedure performed directly on the patient's body.
Device Description: The device consists of instruments used for a surgical procedure (balloon catheter, needles, cannulas, etc.) and is used to facilitate the insertion of bone cement into the spine.
Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The description of the MEDINAUT system and its use does not involve any such testing of specimens.
Input Imaging Modality: The use of fluoroscopic observation with radiographic equipment (like a C-arm) is consistent with a surgical procedure, not an in vitro diagnostic test.
Anatomical Site: The device is used directly on the spine, an anatomical site within the body.

In summary, the MEDINAUT Kyphoplasty System is a surgical device used for a procedure performed directly on a patient, not a device used for testing specimens outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

NDN, HRX

Device Description

It consists of Balloon Catheter, Bone Expander Syringe, Needle Pipe, Needle Pin, Wire Pin (Troca Type, Round Type), Cannula, Expander, Spacer, Cement Pusher, Cement Filler, and Guide Wire. It is supplied sterile and for single disposable use.

The MEDINAUT Kyphoplasty System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The system is substantially equivalent in design, function and intended use to the predicate devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians who are trained in the techniques of bone tanip 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Test Data:
The MEDINAUT Kyphoplasty System complies with the internal quality control procedure of IMEDICOM Co., Ltd. and the characteristics are compared with Kyphon Inflatable Bone Tamp.

Tests performed:

Tensile Bond Strength: Measured outer shaft and Hub with 1mm/sec.
- MEDINAUT Kyphoplasty system: IBE-15; 20.85kgf
- Kyphon Inflatable Bone Tamp: K13A; 14.76kgf
Fatigue strength: No burst and leakage at 15 cycles of maximum pressure limit 400psi.
- MEDINAUT Kyphoplasty system: IBE-10; Pass, IBE-15; Pass, IBE-20; Pass
- Kyphon Inflatable Bone Tamp: K13A; Pass, K09A; Pass, K08A; Pass
Balloon deflation time (seconds):
- MEDINAUT Kyphoplasty system: IBE-10 2ml; 0.50 sec., 3ml; 0.76 sec., IBE-15 3ml; 0.51 sec., 5ml; 1.16 sec., IBE-20 3ml; 0.47 sec., 5ml; 1.12 sec., 7ml; 1.29 sec.
- Kyphon Inflatable Bone Tamp: K13A 2ml; 0.27 sec., 4ml; 0.62 sec., K09A 2ml; 0.28 sec., 4ml; 0.62ml, K08A 2ml; 0.31 sec., 4ml; 0.54 sec., 6ml; 0.69 sec.
Burst pressure constrained: 400 psi at the Constrained jig for 30 seconds.
- MEDINAUT Kyphoplasty system: IBE-10; 3.5ml Pass, IBE-15; 5.5ml Pass, IBE-20; 7.5ml Pass
- Kyphon Inflatable Bone Tamp: K09A; 5.5ml Pass, K08A; 7.5ml Pass
Burst strength unconstraint: Measure the burst inflation pressure.
- MEDINAUT Kyphoplasty system: IBE-10; 250psi, IBE-15; 207psi, IBE-20; 183psi
- Kyphon Inflatable Bone Tamp: K09A; 243psi, K08A; 237psi
Balloon dimension before and after the inflation:
- Initial balloon length: IBE-10; 10mm, IBE-15; 15mm, IBE-20; 20mm
- MEDINAUT Kyphoplasty system:
  - Balloon Diameter after inflation: IBE-10, 3ml inflation; 14.1mm, IBE-15, 5ml inflation; 17.1mm, IBE-20, 7ml inflation; 19.3mm
  - Balloon Length after inflation: IBE-10, 3ml inflation; 16.3mm, IBE-15, 5ml inflation; 22.2mm, IBE-20, 7ml inflation; 29.4mm
- Kyphon Inflatable Bone Tamp:
  - Balloon Diameter after inflation: K09A; 4ml inflation; 15.2mm, K08A, 6ml inflation; 16.8mm
  - Balloon Length after inflation: K09A, 4ml inflation; 20.1mm, K08A, 6ml inflation; 29.2mm
Insertion and withdrawal force: Measure with 0.01m/s of test velocity.
- MEDINAUT Kyphoplasty system:
  - Insertion Force: IBE-10; MEAN 1.24N, IBE-15; MEAN 1.65N, IBE-20; MEAN 2.11N
  - Withdrawal Force: IBE-10; MEAN 1.11N, IBE-15; MEAN 1.42N, IBE-20; MEAN 1.79N
- Kyphon Inflatable Bone Tamp:
  - Insertion Force: K09A; MEAN 1.08N, K08A; MEAN 1.49N
  - Withdrawal Force: K09A; MEAN 0.90N, K08A; MEAN 1.26N

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.

K041454, K010246, K981251

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

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Summary

MEDINAUT Kyphoplasty System 510k Summary APR 0 4 2014

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Mar 24, 2014 1. Date:
Applicant / Sponsor 2.

	Company
Name	IMEDICOM Co., Ltd.
Address	#612 Hanlim Human Tower, 1-40, Guemjung-dong,
Gunpo-si, Gyeonggi-do, Republic of Korea, 435-824
Phone
Fax	+82 31-479-1156
+82 31-479-1157
Contact	Ki Ung. Choi

3. Submission Contact Person

Priscilla Chung / LK Consulting Group USA, Inc.

2651 E Chapman Ave Ste 110,

Fullerton CA 92833

714-202-5789 Tel:

714-409-3357 Fax:

E-mail: info@lkconsultinggroup.com

4. Proposed Device Identification:

Proprietary Name - MEDINAUT Kyphoplasty System Common Name -- Inflatable Bone Tamp Classification Name - Arthroscope

Predicate Device: KyphX Inflatable Bone Tamp, K010246 & K041454 Kyphon Inflatable Bone Tamp, K981251

5. Proposed Device Classifications & Citations:

Classification: Class II

Product Code A:

Regulation Number: 21CFR§888.3027

Review Panel: Orthopedic

Classification: Class II Product Code B: HRX Regulation Number: 21CFR§880.1100

Review Panel: Orthopedic

6. Predicate Device Identification:

510(k) Number: Primary Predicate: K041454 Secondary Predicates: K010246 and K981251 KyphX® Inflatable Bone Tamp Product Name: Manufacturer's Name: Kyphon Inc. (Medtronic)

7. Device Description:

8. Indication for use:

The MEDINAUT Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

9. Bench Test Data:

The MEDINAUT Kyphoplasty System complies with the internal quality control procedure of IMEDICOM Co., Ltd. and the characteristics are compared with Kyphon Inflatable Bone Tamp.

Test	Test Criteria	Test Result
		MÉDINAUT
Kyphoplasty system	Kyphon
Inflatable Bone Tamp
Tensile Bond
Strength	Outer shaft and Hub with the
1mm/sec
Test report#; IMT-TBST12-01	IBE-15; 20.85kgf	K13A; 14.76kgf
Fatigue
strength	No burst and leakage at 15 cycles
of maximum pressure limit
400psi
Test report#; IMT-FST12-01	IBE-10; Pass
IBE-15; Pass
IBE-20; Pass	K13A; Pass
K09A; Pass
K08A; Pass
Test	Test Criteria	Test Result
		MEDINAUT
Kyphoplasty system	Kyphon
Inflatable Bone Tamp
Balloon
deflation time	Compare the performance
(seconds)
Test report:IMT-BDT12-01	IBE-10 2ml; 0.50 sec.	K13A 2ml; 0.27 sec.
		3ml; 0.76 sec.	4ml; 0.62 sec.
		IBE-15 3ml; 0.51 sec.	K09A 2ml; 0.28 sec.
		5ml; 1.16 sec.	4ml; 0.62ml
		IBE-20 3ml; 0.47 sec.	K08A 2ml; 0.31 sec.
		5ml; 1.12 sec.
7ml; 1.29 sec.	4ml; 0.54 sec.
6ml; 0.69 sec.
Burst
pressure
constrained	400 psi at the Constrained jig
for 30 seconds
Test report: IMT-BPC12-08	IBE-10; 3.5ml Pass
IBE-15; 5.5ml Pass
IBE-20; 7.5ml Pass	K09A; 5.5ml Pass
K08A; 7.5ml Pass
Burst strength
unconstraint	Measure the burst inflation
pressure
Test report#: IMT-BST12-01	IBE-10; 250psi
IBE-15; 207psi
IBE-20; 183psi	K09A; 243psi
K08A; 237psi
Balloon
dimension
before and
after the
inflation	Initial balloon length
IBE-10; 10mm
IBE-15; 15mm
IBE-20; 20mm
Test report#: IMT-IDT11-02	Balloon Diameter after
inflation
IBE-10, 3ml inflation;
14.1mm
IBE-15, 5ml inflation;
17.1mm
IBE-20, 7ml inflation;
19.3mm
Balloon Length after
inflation
IBE-10, 3ml inflation;
16.3mm
IBE-15, 5ml inflation;
22.2mm
IBE-20, 7ml inflation;
29.4mm	Balloon Diameter after
inflation
K09A; 4ml inflation;
15.2mm
K08A, 6ml inflation;
16.8mm
Balloon Length after
inflation
K09A, 4ml inflation;
20.1mm
K08A, 6ml inflation;
29.2mm
Insertion and
withdrawal
force	Measure the insertion and
withdrawal force with the
0.01m/s of test velocity.
Test report#: IMT-IFWF12-01	Insertion Force
IBE-10; MEAN 1.24N
IBE-15; MEAN 1.65N
IBE-20; MEAN 2.11N
Withdrawal Force
IBE-10; MEAN 1.11N
IBE-15; MEAN 1.42N
IBE-20; MEAN 1.79N	Insertion Force
K09A; MEAN 1.08N
K08A; MEAN 1.49N
Withdrawal Force
K09A; MEAN 0.90N
K08A; MEAN 1.26N

··

:

...

10. Comparison to the Predicate Device

The MEDINAUT Kyphoplasty System has the same device characteristics as the predicate device, The KyphX Inflatable Bone Tamp System; intended use, materials, design and use concept, sterilization, etc. Only the technical specifications - shape, diameter and length, tension and pull out force - are slightly different.

Product Name	MEDINAUT Kyphoplasty System	KyphX Inflatable Bone Tamp
510(k)	N/A	K010246, K041454 and K981251
Manufacturer	IMEDICOM Co., Ltd.	Kyphon Inc. (Medtronic)
Indication for use	The MEDINAUT Kyphoplasty
System is intended to be used
for the reduction and fixation of
fractures and/or creation of a void
in cancellous bone in the spine.
This includes use during
percutaneous vertebral augmentation.
This system is to be used with
cleared spinal PMMA bone cements
indicated for percutancous vertebral
augmentation, such as kyphoplasty.	KyphX Inflatable Bone Tamps are
intended to be used as conventional
bone tamps for the reduction of
fracture and/or creation of a void in
cancellous bone in the
spine(including use during balloon
kyphoplasty with KyphX HV-RTM
Bone Cement), hand, tibia, radius
and calcaneus.
Articles
Max. Inflation Volume
Initial Length(mm)
Inflated Length(mm)
Inflated Diameter(mm)	IBE-10, IBE-15, IBE-20
3cc, 5cc, 7cc
10, 15, 20
16, 22, 34
14, 17, 19	K08A, K09A, K13A
4cc, 4cc, 6cc
10, 15, 20
17.3, 19.7, 28.2
15.6, 14.3, 15.8
Accessories kit	Needle Pipe,
Needle Pin,
Wire Pin,
Cannula,
Expander,
Spacer,
Cement Pusher,
Cement Filler and Guide Wire	Bone Access Needle,
Introducer System,
Precision Drill,
Cannula,
Expander,
Spacer,
Cement Pusher,
Cement Filler and Guide Wire
Composition of Material
Balloon Tip
Radiopaque Marker
Expander Syringe Body
Accessory Kit	Thermoplastic Polyurethane
Platinum
Polycarbonate and ABS
Stainless Steel and ABS	Thermoplastic Polyurethane
Platinum
Polycarbonate and ABS
Stainless Steel and ABS
Packaging	Pouch, Tyvek Blister Tray,
Cardboard Box	Pouch, Tyvek Blister Tray,
Cardboard Box
Sterilization	Gamma Sterilization	Gamma Sterilization
Biocompatibility	Meets ISO 10993	Meets ISO 10993

・11. Testing and Biocompatibility

Testing performed including functional testing, such as insertion and withdrawal force, puncture force, burst and simulated use which demonstrated that the MEDINAUT Kyphoplasty System is equivalent to the predicates in specifications and performance characteristics. Biocompatibility testing confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum #95-1 entitled Use of International Standards ISO 10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing, and is biocompatible.

12. Contraindications

Instability of posterior wall and/or pedicles

Infection

Severe bleeding

Known allergies to bone cement

Pregnancy

Fractures in which more than 68% of vertebral height is lost

Should not be used if vertebral dimensions or fracture pattern do not allow safe placement and inflation of the balloon

Instability of posterior wall and/ or pedicles

Any known severe allergy to contrast media

13. Warnings

For a transpedicular approach, if the pedicle is not large enough or stable enough to . withstand the procedure, pedicle fracture may occur.
Complications that may occur during a parapedicular approach include pneumothorax and . bleeding
Avoid contract between the balloon and bone cement .
The balloon component of the Vertebral Balloon may fail due to bone splinters and/or . surgical tool contact
Do not inflate the balloon until it has been fully deployed in the vertebral body. Inflating the . balloon prior to full deployment may result in premature balloon failure due to contact between the balloon and the access cannula.
Do not use this product after the expiration date printed on the package. The device may not . be safe or effective beyond its expiration date.
Do not pressurize more than 350PSI. .
Do not put contrast media more than the specified Maximum volume: 10mm(3cc), . 15mm(5cc), 20mm(7cc)
Inflating the vertebral balloon beyond the maximum inflation volume may cause the . balloon to rupture before reaching the maximum inflation pressure.
Inflating the vertebral balloon beyond the maximum inflation pressure may cause the . balloon to rupture before reaching the maximum inflation volume.

Precautions 14.

· It is important to read the instructions for use these precautions prior to device operation.
· Use the Balloon Catheter prior to the use by date noted on the package.
· Do not use damaged products. Before use, inspect the Balloon Catheter and packaging to verify that no damage has occurred.
· Prior to use, the Balloon Catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.
· Do not use this product if you have not been properly trained. The Balloon Catheter should only be used by physicians who are trained in the techniques of bone tanip use. Physicians using the devices should be familiar with the physiology and pathology of the selected anatomy.
· The Balloon Catheter should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images like C-arm.
The Balloon Catheter should only be inflated using an inflation syringe having a 20ml volume capacity.

· Only inflate the Balloon Catheter with liquid contrast medium a 60% solution is recommended.
· Follow manufacturer's instructions for contrast medium indications, usage and cautions.
· Do not use air or other gas to inflate the Balloon Catheter.
· The inflatable component of the Balloon Catheter may fail due to contact with bone splinters, bone cement and/or surgical tools.
· The inflation characteristics of the Balloon Catheter are altered by inflation inside bone.
· Do not re-sterilize and/or reuse. The Balloon Catheter is for single use only.
· Reconditioning, refurbishing, repair, modification, or resterilization of the device to enable further use is expressly prohibited.

15. Mandatory Performance Standard

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices.

16. Voluntary Standards

The MEDINAUT Kyphoplasty System was developed under the auspices of the following Standards.

Standard	Application
ISO 10993-1[2009]	Guidance on the selection of biocompatibility testing
ISO 10993-4[2002]	Applied to the biological evaluation tests for interactions
with blood
ISO 10993-5[2009]	Applied to the biological evaluation tests for In Vitro
cytotoxicity
ISO 10993-10[2010]	Applied to the intracutaneous reactivity test & skin
sensitization test
ISO 10993-11[2006]	Applied to tests for systemic toxicity
ISO 11137-1:2006
ISO 11137-2: 2012
ISO 11137-3:2006	Applied to sterilization validation
ISO 11607-1:2006
ISO 11607-2: 2006
ISO 14971:2007	Applied to risk management
ISO 9001:2008	Applied to the certification of the quality management system
of Medicom Co., Ltd
ISO 13485:2003
ASTM F 1980-02	Applied to accelerated aging testing
ISO 11737-1:2006
ISO 11737-2: 2009	Applied to sterilization validation
ISO 11737-3:2004
EN 556-1:2001

17. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification IMEDICOM Co., Ltd. submits that the MEDINAUT Kyphoplasty System in this submittal is substantially equivalent to the predicate System, the KyphX Inflatable Bone Tamp System, as described within this submittal.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with flowing lines.

Public Health Service

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

April 4, 2014

IMEDICOM Co., Ltd. % Ms. Priscilla Chung Consultant/Official Correspondent LK Consulting Group USA, Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92833

Re: K133669

Trade/Device Name: MEDINAUT Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: February 11, 2014 Received: February 18, 2014

Dear Ms. Chung:

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

Page 2 - Ms. Priscilla Chung

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/Safetv/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/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Ronald P. Jean -S for

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

Enclosure

K133669 - Page 1 of 1

Indications for Use

510(k) Number (if known): K 133669

Device Name: MEDINAUT Kyphoplasty System

Indications for Use: The MEDINAUT Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

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

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)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133669