# K984623: Maxim Removable Molded Poly Tibia

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 5, 1999 after 65 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “K915132.”, which our checks could not confirm as its predicate.

## Most influential descendants
- K060525: Vanguard Removable Molded Poly Tibia (2006), 16 descendants of its own
- K102580: Vanguard Removable Molded Poly Tibia (2011), 9 descendants of its own
- K122160: Vanguard XP Knee System (2013), 6 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own

## Indications for use
Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

Source page: https://510kreport.com/device/K984623
Methodology: https://510kreport.com/methodology