(126 days)
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.
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.
This device is a medical device, not an AI/ML device, so many of the requested fields are not applicable.
Here's an analysis of the provided 510(k) summary for the MEDINAUT Kyphoplasty System, focusing on acceptance criteria and performance data:
The MEDINAUT Kyphoplasty System is a physical medical device (an inflatable bone tamp system) used in kyphoplasty procedures. The "acceptance criteria" and "study" described are primarily bench tests comparing the device's physical properties and performance against a predicate device, rather than clinical studies or evaluations of an AI model's diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the format of pass/fail thresholds for each test. Instead, it presents "Test Criteria" which are more akin to the methodology or conditions of the test, and then provides "Test Result" for both the MEDINAUT Kyphoplasty System and the predicate device (Kyphon Inflatable Bone Tamp). The implicit acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device. This means the new device's performance should be comparable to or better than the predicate's, and not raise new questions of safety or effectiveness.
| Test | Test Criteria | MEDINAUT Kyphoplasty System (Reported Performance) | Kyphon Inflatable Bone Tamp (Predicate Performance) |
|---|---|---|---|
| Tensile Bond Strength | Outer shaft and Hub with 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; PassIBE-15; PassIBE-20; Pass | K13A; PassK09A; PassK08A; Pass |
| Balloon Deflation Time | Compare the performance (seconds), Test report:IMT-BDT12-01 | 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. | K13A 2ml; 0.27 sec.4ml; 0.62 sec.K09A 2ml; 0.28 sec.4ml; 0.62mlK08A 2ml; 0.31 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 PassIBE-15; 5.5ml PassIBE-20; 7.5ml Pass | K09A; 5.5ml PassK08A; 7.5ml Pass |
| Burst Strength Unconstrained | Measure the burst inflation pressure, Test report #: IMT-BST12-01 | IBE-10; 250psiIBE-15; 207psiIBE-20; 183psi | K09A; 243psiK08A; 237psi |
| Balloon Dimension before and after 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: 14.1mmIBE-15, 5ml: 17.1mmIBE-20, 7ml: 19.3mmBalloon Length after inflation:IBE-10, 3ml: 16.3mmIBE-15, 5ml: 22.2mmIBE-20, 7ml: 29.4mm | Balloon Diameter after inflation:K09A, 4ml: 15.2mmK08A, 6ml: 16.8mmBalloon Length after inflation:K09A, 4ml: 20.1mmK08A, 6ml: 29.2mm |
| Insertion and Withdrawal Force | Measure the insertion and withdrawal force with 0.01m/s test velocity, Test report #: IMT-IFWF12-01 | Insertion Force:IBE-10; MEAN 1.24NIBE-15; MEAN 1.65NIBE-20; MEAN 2.11NWithdrawal Force:IBE-10; MEAN 1.11NIBE-15; MEAN 1.42NIBE-20; MEAN 1.79N | Insertion Force:K09A; MEAN 1.08NK08A; MEAN 1.49NWithdrawal Force:K09A; MEAN 0.90NK08A; MEAN 1.26N |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size (e.g., number of devices tested for each parameter) for the bench tests. It refers to "IBE-10," "IBE-15," "IBE-20" for the applicant's device and "K13A," "K09A," "K08A" for the predicate, which likely correspond to different sizes or models of the devices tested. Without further detail, we cannot determine the n for each specific test.
The data provenance is from bench testing conducted by IMEDICOM Co., Ltd. (Republic of Korea) and compared against the Kyphon Inflatable Bone Tamp. This is laboratory data, not patient-derived data, and therefore the concepts of "country of origin of the data," "retrospective or prospective" (in a clinical sense) are not directly applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device and study. The "ground truth" for these bench tests is established by physical measurement and engineering standards, not by expert interpretation of medical images or patient outcomes. The physical properties (e.g., tensile strength, burst pressure) are objectively measurable.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used for establishing ground truth in human-reviewed data sets, especially when there's variability in expert interpretations. Bench tests rely on standardized measurement protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where the output of the AI is compared to human readers' performance, with or without AI assistance, on a set of clinical cases. The MEDINAUT Kyphoplasty System is a physical surgical tool, not a diagnostic AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. The device is a physical, non-AI medical tool. The concept of "standalone performance" without human intervention doesn't apply to a surgical instrument that is used by a surgeon.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is based on engineering measurements and specifications of the physical properties (e.g., strength, pressure resistance, dimensions, forces). The comparison is made against the performance of a legally marketed predicate device to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design of the device is based on engineering principles and iterative development, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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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 |
| PhoneFax | +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
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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:
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.
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 | |
|---|---|---|---|
| MÉDINAUTKyphoplasty system | KyphonInflatable Bone Tamp | ||
| Tensile BondStrength | Outer shaft and Hub with the1mm/secTest report#; IMT-TBST12-01 | IBE-15; 20.85kgf | K13A; 14.76kgf |
| Fatiguestrength | No burst and leakage at 15 cyclesof maximum pressure limit400psiTest report#; IMT-FST12-01 | IBE-10; PassIBE-15; PassIBE-20; Pass | K13A; PassK09A; PassK08A; Pass |
| Test | Test Criteria | Test Result | |
| MEDINAUTKyphoplasty system | KyphonInflatable Bone Tamp | ||
| Balloondeflation 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. | ||
| Burstpressureconstrained | 400 psi at the Constrained jigfor 30 secondsTest report: IMT-BPC12-08 | IBE-10; 3.5ml PassIBE-15; 5.5ml PassIBE-20; 7.5ml Pass | K09A; 5.5ml PassK08A; 7.5ml Pass |
| Burst strengthunconstraint | Measure the burst inflationpressureTest report#: IMT-BST12-01 | IBE-10; 250psiIBE-15; 207psiIBE-20; 183psi | K09A; 243psiK08A; 237psi |
| Balloondimensionbefore andafter theinflation | Initial balloon lengthIBE-10; 10mmIBE-15; 15mmIBE-20; 20mmTest report#: IMT-IDT11-02 | Balloon Diameter afterinflationIBE-10, 3ml inflation;14.1mmIBE-15, 5ml inflation;17.1mmIBE-20, 7ml inflation;19.3mmBalloon Length afterinflationIBE-10, 3ml inflation;16.3mmIBE-15, 5ml inflation;22.2mmIBE-20, 7ml inflation;29.4mm | Balloon Diameter afterinflationK09A; 4ml inflation;15.2mmK08A, 6ml inflation;16.8mmBalloon Length afterinflationK09A, 4ml inflation;20.1mmK08A, 6ml inflation;29.2mm |
| Insertion andwithdrawalforce | Measure the insertion andwithdrawal force with the0.01m/s of test velocity.Test report#: IMT-IFWF12-01 | Insertion ForceIBE-10; MEAN 1.24NIBE-15; MEAN 1.65NIBE-20; MEAN 2.11NWithdrawal ForceIBE-10; MEAN 1.11NIBE-15; MEAN 1.42NIBE-20; MEAN 1.79N | Insertion ForceK09A; MEAN 1.08NK08A; MEAN 1.49NWithdrawal ForceK09A; MEAN 0.90NK08A; MEAN 1.26N |
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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 KyphoplastySystem is intended to be usedfor the reduction and fixation offractures and/or creation of a voidin cancellous bone in the spine.This includes use duringpercutaneous vertebral augmentation.This system is to be used withcleared spinal PMMA bone cementsindicated for percutancous vertebralaugmentation, such as kyphoplasty. | KyphX Inflatable Bone Tamps areintended to be used as conventionalbone tamps for the reduction offracture and/or creation of a void incancellous bone in thespine(including use during balloonkyphoplasty with KyphX HV-RTMBone Cement), hand, tibia, radiusand calcaneus. |
| ArticlesMax. Inflation VolumeInitial Length(mm)Inflated Length(mm)Inflated Diameter(mm) | IBE-10, IBE-15, IBE-203cc, 5cc, 7cc10, 15, 2016, 22, 3414, 17, 19 | K08A, K09A, K13A4cc, 4cc, 6cc10, 15, 2017.3, 19.7, 28.215.6, 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 MaterialBalloon TipRadiopaque MarkerExpander Syringe BodyAccessory Kit | Thermoplastic PolyurethanePlatinumPolycarbonate and ABSStainless Steel and ABS | Thermoplastic PolyurethanePlatinumPolycarbonate and ABSStainless 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.
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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.
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- · 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 interactionswith blood |
| ISO 10993-5[2009] | Applied to the biological evaluation tests for In Vitrocytotoxicity |
| ISO 10993-10[2010] | Applied to the intracutaneous reactivity test & skinsensitization 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 systemof 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.
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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
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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
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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
§ 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.”