# K993836: Generation 4 Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 19, 2001 after 768 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P17004: Surgical Simplex P Radiopaque Bone Cement. Number could not be read Summary page 2.

## Most influential descendants
- K051532: Cobalt G HV Bone Cement (2005), 23 descendants of its own
- K062273: Spacer-G Temporary Hip Prosthesis (2008), 20 descendants of its own
- K101356: Spacer-G and Spacer-K (2011), 19 descendants of its own
- K112470: 2GC Hip/Knee Modular Spacer (2012), 16 descendants of its own
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (2019), 5 descendants of its own

## Indications for use
GENERATION 4 Bone Cement is intended for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

Source page: https://510kreport.com/device/K993836
Methodology: https://510kreport.com/methodology