# K021765: Cement Restrictor, Small and Large

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Aug 16, 2002 after 79 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923616 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001932: Tornier Cement Restrictor, Tornier (2000)
- K955631: Orthoplug Hard Bone Design, Sunmed, Inc. (1996) Summary page 2.
- K955632: Orthoplug Soft Bone Design, Sunmed, Inc. (1996) Summary page 2.
- K001733: Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series, Zimmer, Inc. (2000)
- K923616: Omniflex-C Uhmwpe Mid-Shaft Restrictor, Osteonics Corp. (1992) Summary page 2.

## Most influential descendants
- K210062: Mectaplug PE II (2021), 0 descendants of its own

## Indications for use
Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

Source page: https://510kreport.com/device/K021765
Methodology: https://510kreport.com/methodology