(89 days)
K1222160
No
The 510(k) summary describes a mechanical knee replacement system and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The testing described is purely mechanical.
Yes
The device is intended for the replacement of a total knee joint, which addresses painful and disabled knee joints resulting from various arthritic conditions and deformities. This falls under the definition of a therapeutic device as it is used to treat or alleviate a medical condition.
No
Explanation: The device is a total knee replacement system intended for surgical implantation, not for diagnosing medical conditions. Its purpose is to replace a diseased or damaged knee joint.
No
The device description clearly states it is a total knee replacement system consisting of physical components like femoral components, tibial trays, bearings, and instrumentation, all made of materials like Co-Cr-Mo and El poly. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "replacement of a total knee joint". This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the components of a knee replacement system (femoral component, tibial trays, bearings, etc.), which are physical implants.
- Performance Studies: The performance studies focus on mechanical testing of the implant components (stability, fatigue, fixation), not on the analysis of biological samples.
- Anatomical Site: The anatomical site is the "Knee joint", indicating a device used within the body.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Intended use of the device
The Vanguard™ XP Knee System is intended for replacement of a total knee joint and the preservation of the anterior and/or posterior cruciate ligament (ACL/PCL) when used in conjunction with a femoral, tibial and patellar component.
Indications for use
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok") femoral components. tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components* are intended only for uncemented biologic fixation application.
*where available
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, MBV, OIY
Device Description
The purpose of the submission is to update the locking mechanism cleared in K122160.
The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of Co-Cr-Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo (with locking bar), and dual bearings machined of El poly. Biomet® patellae can be used with the Vanguard XP Knee System. Both the XP femoral and the XP-CR tibial components are available with a previously cleared porous plasma spray (PPS) coating of titanium alloy and Biomet's Interlok coarse blasted finishes. The Vanguard XP-XP tibial components are available in Biomet's Interlok® coarse blasted finish. Porous coated femoral and tibial components are indicated for cemented and uncemented biological fixation application. Non-coated coarse blasted (Interlok®) femoral and tibial components are indicated for cemented application only. Accessory components are available including removable femoral pegs and femoral augments.
The Vanguard™ XP Knee System is made up of multiple components. including: instrumentation, femoral components, several types of bearings and tibial trays.
The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K122160, K904448, and K113550) in terms of design. material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject locking bar mechanism. tibial and bearing components of the Vanguard™ XP Knee System utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of K122160 and subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Nonclinical) section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
SUMMARY OF NON-CLINICAL TESTS
The following tests/rationale were performed for the new Vanguard® XP Knee System:
- Tibiofemoral Mechanical Stability / Locking Mechanism Test .
- Static Locking Mechanism Test .
- Tibial Fixation and Cyclic Locking Mechanism Test
- Cyclic Fatigue of Tibial Tray Test .
- Tibial/Bearing Assembly Verification Test .
- Locking Bar Insertion and Push-Out Test .
- MRI Compatibility Rationale
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: N/A
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA.
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
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.
K1222160 Vanguard® XP Knee System (JWH, MBH, MBV, OIY)
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.
K113550 Vanguard™ Knee System (JWH, MBH, OIY), K904448 Townley Total Knee (JWH)
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
K132873 (1/3)
Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in large, bold, sans-serif font, with a line above the letters "ET". Below the logo is the text "MANUFACTURING CORP." in a smaller, sans-serif font. The text is left-aligned and the image is in black and white.
DEC 1 1 2013
510(k)SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact | |
| person | Julie B. Gantenberg, M.S. |
| Date prepared | September 5, 2013 |
| Name of device | |
| Trade or proprietary | |
| name | Vanguard™ XP Knee System |
| Common or usual | |
| name | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial metal/polymer porous- coated |
| uncemented prosthesis (§888.3565) |
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (§888.3560)
Knee joint patellofemorotibial semi-constrained UHMWPE
pegged uncemented polymer/metal/polymer (§888.3560)
Knee joint patellofemorotibial polymer+Additive/metal/polymer
+Additive semi-constrained cemented prosthesis (§888.3560) |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.3565
21CFR §888.3560 |
| Product Code(s) | JWH, MBH, MBV, OIY |
| Legally marketed device(s)
to which equivalence is
claimed | K1222160 Vanguard® XP Knee System (JWH, MBH, MBV, OIY)
K113550 Vanguard™ Knee System (JWH, MBH, OIY)
K904448 Townley Total Knee (JWH) |
| Reason for 510(k)
submission | Modification of the locking mechanism cleared in K122160 XP
System |
| Device description | The purpose of the submission is to update the locking
mechanism cleared in K122160. |
| | The Vanguard XP Knee System is a total knee replacement
system that consists of a femoral component composed of Co-Cr-
Mo, two styles of tibial trays/plates manufactured of Co-Cr-Mo
(with locking bar), and dual bearings machined of El poly.
Biomet® patellae can be used with the Vanguard XP Knee
System. Both the XP femoral and the XP-CR tibial components
are available with a previously cleared porous plasma spray (PPS)
coating of titanium alloy and Biomet's Interlok coarse blasted
finishes. The Vanguard XP-XP tibial components are available
in Biomet's Interlok® coarse blasted finish. Porous coated
femoral and tibial components are indicated for cemented and
uncemented biological fixation application. Non-coated coarse
blasted (Interlok®) femoral and tibial components are indicated
for cemented application only. Accessory components are
available including removable femoral pegs and femoral
augments. |
| Intended use of the device | The Vanguard™ XP Knee System is intended for replacement of a
total knee joint and the preservation of the anterior and/or posterior
cruciate ligament (ACL/PCL) when used in conjunction with a
femoral, tibial and patellar component. |
| Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis,
rheumatoid arthritis, or traumatic arthritis where one or more
compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
2.
Correction or revision of unsuccessful osteotomy, arthrodesis,
3.
or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous
coatings are indicated for cemented and uncemented biological
fixation application. Non-coated (Interlok") femoral components.
tibial tray components and all polyethylene patellar components are
indicated for cemented application only. Regenerex components*
are intended only for uncemented biologic fixation application.
*where available |
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800 348 9500 Office: 574 267.6639 Main Fax: 574 267.8137 www.biomet.com
Shipping Address: onal
56 East Bell Drive
Warsaw, IN 46582
1
Image /page/1/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font. The text is black and the background is white.
·
.
2
Image /page/2/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular shape. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The logo is black and white.
The Vanguard™ XP Knee System is made up of multiple components. including: instrumentation, femoral components, several types of bearings and tibial trays.
The technological characteristics of the Vanguard™ XP Knee System are the same as those of predicate devices (K122160, K904448, and K113550) in terms of design. material, and principle of operation with the exception of slight modifications as described in this 510(k). The subject locking bar mechanism. tibial and bearing components of the Vanguard™ XP Knee System utilize the identical manufacturing processes as the predicates. The previously cleared, porous plasma spray characterization data on identical substrate was provided in K113550 and used in support of K122160 and subject 510(k). The porous plasma spray coating on the ASTM F75 substrate is for both cemented and uncemented, biologic fixation. Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Nonclinical) section.
1 PERFORMANCE PERFORMANCE PERFORMANCE DATABLE SUMMARY OF NON-CLINICAL TESTS
Performance Test Summarv-New Device
The following tests/rationale were performed for the new Vanguard® XP Knee System:
- Tibiofemoral Mechanical Stability / Locking Mechanism Test .
- Static Locking Mechanism Test .
- o Tibial Fixation and Cyclic Locking Mechanism Test
- Cyclic Fatigue of Tibial Tray Test .
- Tibial/Bearing Assembly Verification Test .
- Locking Bar Insertion and Push-Out Test .
- MRI Compatibility Rationale
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: N/A
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA.
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is positioned to the right of the text, and the overall design is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2013
Biomet Manufacturing Corporation Julie B. Gantenberg, M.S. Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K132873
Trade/Device Name: Vanguard XP Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: MBH, JWH, MBV, OIY Date: September 5, 2013 Received: September 13, 2013
Dear Ms. Gantenberg:
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 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
4
Page 2 - Julie B. Gantenberg, M.S.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 vours.
Ronaldille Nean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132873
Device Name: Vanguard™ XP Knee System
Indications For Use:
- I. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation. Non-coated (Interlok") femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.
- Where Available
Prescription Use ... × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/14 description: The image shows a logo with the text "Casey L. Hanley, Rh.D." on the top left. Below a horizontal line, the text "Division of Orthopedic Devices" is present. The logo also features a stylized graphic, possibly representing the letters "FDA", integrated into the design.
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