510(k) · Cleared
ClearedRestoration Anatomic Shell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 22, 2021 as substantially equivalent to K153345 (Stryker Orthopaedics, 2016) after a 28-day review. Its family tree reaches back 9 generations to 1994. 5 later devices descend from it.
- Decided
- Apr 22, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921308 (1994). 118 ancestors in all, the oldest K894124 (1989). 5 later devices descend from it, 1 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 deviceK210893 Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2021
- 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 · 2 generations on · 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 deviceK210893 Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2021
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 · 2 generations on0descendants
- 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) | K210893 | Restoration Anatomic Shell | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2021 | — |
| +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 | — |
| +2 | 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 |
| 1994 | 7 | 0 |
| 1995 | 9 | 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 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? (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 |
|---|---|---|---|
| * | K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateSummary page 5…ct Codes: LPH Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed: • Restoration Anatomic Shell (K153345) Legally Marketed Reference Device Used to Support Substantial Equivalence: • Restoration Acetabular Wedge Augment (K15334… | 2016 |
| † | K102019 | Restoration Acetabular Wedge Augments | 2011 |
| † | K151264 | Restoration Anatomic Shell | 2015 |
| † | K142462 | Restoration Anatomic Shell | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | 2023 | 4 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 43 of the 118 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.
- 7 other devices also cite its predicate K153345.
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. 2021, 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?
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for…
Read the full statement (151 words)
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner:
The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration Anatomic Shell is indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210893: Restoration Anatomic Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210893
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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