510(k) · Cleared
ClearedRestoration® Modular Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 27, 2020 as substantially equivalent to K121308 (Howmedica Osteonics Corp., 2012) and 2 other predicates after a 184-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- May 27, 2020
- Review
- 184 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K921308 (1994). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 4 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 3 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 2 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- This deviceK193233 Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −4 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −3 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −1 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| 0 (this device) | K193233 | Restoration® Modular Hip System | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | 2020 | — |
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 |
| 2012 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K121308 | Hip SystemsSummary page 6…Restoration® Modular Hip System Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed: x Howmedica Osteonics Hip Systems – K121308 x Howmedica Osteonics Restoration Modular System – K022549 x Howmedica Osteonics 2 Piece Modular Hip Stem – K013106 De… | 2012 |
| * | K022549 | Restoration Modular SystemSummary page 6…eted Predicate Device to Which Substantial Equivalence is Claimed: x Howmedica Osteonics Hip Systems – K121308 x Howmedica Osteonics Restoration Modular System – K022549 x Howmedica Osteonics 2 Piece Modular Hip Stem – K013106 Device Description The Restoration® Modular Hip System is a bowed… | 2002 |
| * | K013106 | 2 Piece Modular Hip StemSummary page 6…med: x Howmedica Osteonics Hip Systems – K121308 x Howmedica Osteonics Restoration Modular System – K022549 x Howmedica Osteonics 2 Piece Modular Hip Stem – K013106 Device Description The Restoration® Modular Hip System is a bowed shaped femoral distal stem which is plasma- sprayed with comme… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 10 of the 16 ancestors have a recall of any class.
- 7 other devices also cite its predicate K121308.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed; and,
Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indications specific to the Restoration Modular Hip System:
The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.
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/K193233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193233: Restoration® Modular Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193233
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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