510(k) · Cleared
ClearedArtisan Bone Plug, Universal Cement Restrictor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics, Dba Stryker Orthopaedics · LZN Cement Obturator
Cleared on May 20, 2022 as substantially equivalent to K951860 (Howmedica Corp., 1995) and 3 other predicates after a 59-day review. Its family tree reaches back 9 generations to 1994. 5 later devices descend from it.
- Decided
- May 20, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K921308 (1994). 120 ancestors in all, the oldest K894124 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- 2 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- 1 generation backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- This deviceK220838 Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics · 2022
- Descendant · cites it directly · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · cites it directly · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
- Descendant · 2 generations on · 0 of its ownK250989 Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025
- Descendant · 2 generations on · 0 of its ownK240418 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Show all 9 generations
- Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 8 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 7 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 6 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 5 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 4 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- 3 generations backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- 2 generations backK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- 1 generation backK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- This deviceK220838 Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics · 2022
Most influential descendants
Showing 5 of 5 · See all- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on2descendants
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · cites it directly0descendants
- K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics) · 2025 · 2 generations on0descendants
- K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −8 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −7 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −6 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −5 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −4 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| −3 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| −2 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| −1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| 0 (this device) | K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022 | — |
| +1 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +1 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
| +2 | K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025 | — |
| +2 | K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951860 | Howmedice Bone PlugSummary page 5…JDI – Prosthesis, hip, semi-constrained, metal/polymer, cemented Legally Marketed Device to Which Substantial Equivalence is Claimed: Artisan Bone Plug – K951860 Universal Cement Restrictor – K924323 Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: Uni… | 1995 |
| * | K924323 | The Universal Bone Cement ResistorSummary page 5…emi-constrained, metal/polymer, cemented Legally Marketed Device to Which Substantial Equivalence is Claimed: Artisan Bone Plug – K951860 Universal Cement Restrictor – K924323 Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: Universal Distal Spacer – K914406, K15334… | 1993 |
| * | K914406 | PT II Distal Cement SpacerSummary page 5…ne Plug – K951860 Universal Cement Restrictor – K924323 Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: Universal Distal Spacer – K914406, K153345 Device Description: The Artisan Bone Plug and Universal Cement Restrictor are commercially available devices that have… | 1991 |
| * | K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateSummary page 5…K951860 Universal Cement Restrictor – K924323 Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: Universal Distal Spacer – K914406, K153345 Device Description: The Artisan Bone Plug and Universal Cement Restrictor are commercially available devices that have been dete… | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 43 of the 120 ancestors have a recall of any class.
- Of its descendants, K233498 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K951860.
How does its category compare?
All LZN devicesLZN Cement Obturator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LZN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LZN
Too few LZN 510(k)s in any year since 2007 to give a median.
Recalls per year · LZN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZN
6in 2025
MAUDE reports naming product code LZN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 1 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220838: Artisan Bone Plug, Universal Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220838
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026