(197 days)
No
The 510(k) summary describes a mechanical knee replacement device and does not mention any AI or ML components, image processing, or data-driven performance metrics.
Yes
The device is a knee joint replacement, which is a therapeutic intervention for painful and disabled knee joints resulting from various arthritic conditions or failed prior procedures.
No
The device description and intended use primarily describe a knee joint replacement system (Vanguard™ Anterior Stabilized Tibial Bearings) used for treatment, not for diagnosing a condition.
No
The device description clearly describes physical components (tibial bearings, femoral components, tibial tray components, patellar components) intended for surgical implantation in the knee joint. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to replace damaged knee joints. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details components of a knee replacement system (femoral components, tibial tray, patellar components, tibial bearings). These are physical implants, not reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
The device is a medical device intended for surgical implantation to treat knee joint conditions.
N/A
Intended Use / Indications for Use
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid l. arthritis, traumatic arthritis where one or more compartments are involved;
- correction of varus, valgus or posttraumatic deformity; 2.
- correction of revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated and all polyethylene patellar components are indicated for cemented application only.
Product codes
JWH, MBH
Device Description
The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the knee joint. They offer increased anterior and posterior stabilization to the articular portions. They are to be used with the Vanguard™ CR femoral components cleared in K915132, and with any Biomet commercially available patella button.
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
No clinical testing was necessary to support the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 05 0222
AUG 1 6 2005
BIOMET
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
Warsaw, IN 46582
FDA Registration # 1825034 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, IN 46581-0587
Telephone: (574) 267-6639 Ext. 1568
Fax: (574) 372-1683 |
| Proprietary Name: | Vanguard™ Anterior Stabilized Tibial Bearings. |
| Common Name: | Knee Prosthesis |
| Classification Name: | Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained
cemented prosthesis (§888.3560).
Knee joint, patellofemorotibial, metal/polymer porous coated uncemented
prosthesis (§888.3565). |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim Accel (Vanguard™) CR – Lipped Tibial Bearings – K023546
The Vanguard™ Anterior Stabilized Tibial Bearings are intended for use in the Device Description: Device Description. "The Valleula "The knee joint. They offer increased anterior and posterior replacement on the articular portions of they are to be used with the Vanguard™ CR femoral stablization and the with grouter sagtas components cleared in K915132, both of which were Components citation in 10259 10 the title the new learners and withing any Biomet commercially available patella button.
Intended Use:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid l. arthritis, traumatic arthritis where one or more compartments are involved;
- correction of varus, valgus or posttraumatic deformity; 2.
- correction of revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
행
I·AX 574.267.8137
E-MAIL biomet@biomet.com
1
KOS0222
p.2/2
Femoral components and tibial tray components with porous coating are indicated for Femoral components and trail tray components with percused (Interlok") devices
cemented and uncemented biological fixation application. Non-coated amiliation only cemented and uncemented blological fixation upprication.
and all polyethylene patellar components are indicated for cemented application only.
Summary of Technologies: The Vanguard™ Anterior Stabilized Tibial Bearings have the same intended Summary of Technologies: The Vanguard™ Anterior Stablined Trical Pour Maring on
use, are made of the same materials and have the same or similar design and sizing as the pre bearings.
Risk analysis has demonstrated equivalence between the modified and predicate Non-Clinical Testing: devices.
No clinical testing was necessary to support the claim of substantial equivalence. Clinical Testing:
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2005
Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. . . . . P.O. Box 587 Warsaw, Indiana 46581-0578
Re: K050222
KV50222 Regulation Number: 21 CFR 888.3560, 21 CFR 888.3565 Regulation Name: Zr CFR 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 cemented prosthesis, Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II
Product Code: JWH, MBH Dated: July 22, 2005 Received: July 26, 2005
Dear Mr. Baker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to regars attent date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in easonance with the provisions of the Federal Food, Drug, devices mat have been recure approval of a premarket approval application (PMA). and Costicule rece (110) that the device, subject to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the simment of the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassified (600 a00 royals. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that i Dr. Bratian that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I catal statutes and equirements, including, but not limited to: registration and listing (21 comply with an the Her Frequirements, and manufacturing practice requirements as set CI K Part 607); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Gary Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manxeing of substantial equivalence of your device to a legally premarket notification: The PDF intembers of the more and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you uesn't specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Colliact the Office of Complance an (21 notification" (21CFR Part 807.97). You may obtain Misblanding of reference to premains on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octiser http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smectry, Joan,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications For Use
510(k) Number (IF KNOWN)__K050222
Device Name: Vanguard™ Anterior Stabilized Tibial Bearings
Indications For Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic r annut and Gioone or more compartments are involved;
- arthritis where arus, valgus or posttraumatic deformity; 2.
... ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- correction of varias, vargus of postfaultatio decommy, arthrodesis, or failure of previous joint 3. replacement procedure.
Femoral components and tibial tray components with porous coating are indicated for cemented and Femoral components and thial tray components with porcus couldness and all polyethylene patellar ancements are indicated for cemented application only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
and/or
Over-The-Counter Use_ (Per 21 CFR 807 Subpart C)
ﺘﺴﺘﺨﻴﺘﺮ ﺑﺘﻘ
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K050222 |