510(k) · Cleared
Recalled · Class II · 2012Restoration Modular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 23, 2002 as substantially equivalent to K013106 (Howmedica Osteonics Corp., 2002) after a 53-day review. Its family tree reaches back 4 generations to 1994. 54 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 23, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921308 (1994). 14 ancestors in all. 54 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 3 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 2 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 1 generation backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- This deviceK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- Descendant · cites it directly · 24 of its ownK032380 Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 9 of its ownK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · cites it directly37descendants
- K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · 2 generations on27descendants
- K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003 · cites it directly24descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 2 generations on13descendants
- K113556Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −3 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −2 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −1 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| 0 (this device) | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| +2 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| +1 | K032380 | Wagner Cone Prosthesis | Centerpulse Orthopedics, Inc. | 2003 | — |
| +2 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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 LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K013106 | 2 Piece Modular Hip Stem | 2002 |
What descends from it? (54)
See all 546 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090757 | Biomet Modular Femoral Revision System | 2009 | 37 |
| K032380 | Wagner Cone Prosthesis | 2003 | 24 |
| K213129 | Restoration Modular 115mm Conical Distal Stem | 2021 | 8 |
| K062383 | Unisyn HA Plasma Modular Hip | 2006 | 1 |
| K242315 | Resolve Modular Revision Hip Stem | 2025 | 0 |
| K193233 | Restoration® Modular Hip System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2012 | Class II | Z-2487-2012 | Device Design | Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section. |
| Apr 2, 2009 | Not classified | Z-1642-2009 | Process control | Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell… |
| Nov 21, 2008 | Not classified | Z-0884-2009 | Labeling mix-ups | Stryker became aware of a lot for lot mix up. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 8 of the 14 ancestors have a recall of any class.
- Of its descendants, K090757 (Biomet, Inc., 2009) has gone furthest, with 37 descendants of its own.
- 5 other devices also cite its predicate K013106.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The RestorationTMModular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular Components. These femoral stems are designed to be press fit into the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022549: Restoration Modular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022549
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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