# K220838: Artisan Bone Plug, Universal Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics, Dba Stryker Orthopaedics
- Decided: May 20, 2022 after 59 days
- Product code: LZN (Cement Obturator)
- 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: 9 generations back to K921308 (1994). 120 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951860: Howmedice Bone Plug, Howmedica Corp. (1995) Summary page 5.
- K924323: The Universal Bone Cement Resistor, Biodynamic Technologies, Inc. (1993) Summary page 5.
- K914406: PT II Distal Cement Spacer, Osteonics Corp. (1991) Summary page 5.
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 5.

## Most influential descendants
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own
- K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (2026), 0 descendants of its own
- K250989: Stryker and Serf hip devices (2025), 0 descendants of its own
- K240418: Stryker Orthopaedics Hip Systems Labeling Update (2024), 0 descendants of its own

## Indications for use
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal. For cement spacers, mid-shaft restrictors and Cement Plugs: » In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

Source page: https://510kreport.com/device/K220838
Methodology: https://510kreport.com/methodology