510(k) · Cleared
Recalled · Class II · 2017Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 9, 2015 as substantially equivalent to K983382 (Osteonics Corp., 1998) and 6 other predicates after a 105-day review. Its family tree reaches back 7 generations to 1994. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 9, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 7 generations to K921308 (1994). 39 ancestors in all, the oldest K903362 (1990). 21 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 6 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 5 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 4 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 3 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 2 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- 1 generation backK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- This deviceK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · cites it directly · 10 of its ownK171768 Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
- Descendant · 2 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · cites it directly10descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 2 generations on8descendants
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 2 generations on7descendants
- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −6 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −5 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −4 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −3 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −2 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| −1 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| 0 (this device) | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | — |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +1 | K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | 12 |
| +2 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II… | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019 | — |
| +2 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K983382 | Osteonics HA Generation II Acetabular Component SystemSummary page 9…K143085 Page 2 of 6 Legally Marketed Device to Which Substantial Equivalence is claimed: Trident PSL Shell (K983382) Trident Tritanium Shell (K010170) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II… | 1998 |
| * | K010170 | Trident Porous Titanium Acetabular ComponentSummary page 9…Page 2 of 6 Legally Marketed Device to Which Substantial Equivalence is claimed: Trident PSL Shell (K983382) Trident Tritanium Shell (K010170) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II Femoral Stem (K120578) Secur-Fit… | 2001 |
| * | K013676 | Trident Hemispherical Acetabular ShellsSummary page 9…of 6 Legally Marketed Device to Which Substantial Equivalence is claimed: Trident PSL Shell (K983382) Trident Tritanium Shell (K010170) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II Femoral Stem (K120578) Secur-Fit Advanced Stem (K122853) Anato Hip Stem… | 2001 |
| * | K081171 | Tritanium Acetabular Shell SystemSummary page 9…stantial Equivalence is claimed: Trident PSL Shell (K983382) Trident Tritanium Shell (K010170) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II Femoral Stem (K120578) Secur-Fit Advanced Stem (K122853) Anato Hip Stem (K123604) Device Description: The devices… | 2008 |
| * | K120578 | Accolade II Hip StemSummary page 9…rident PSL Shell (K983382) Trident Tritanium Shell (K010170) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II Femoral Stem (K120578) Secur-Fit Advanced Stem (K122853) Anato Hip Stem (K123604) Device Description: The devices covered by this submission include… | 2012 |
| * | K122853 | Novel Fit and Fill StemSummary page 9…Tritanium Shell (K010170) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II Femoral Stem (K120578) Secur-Fit Advanced Stem (K122853) Anato Hip Stem (K123604) Device Description: The devices covered by this submission include Stryker Orthopaedics Acetabular Sh… | 2013 |
| * | K123604 | Abg Iii Monolithic Hip StemSummary page 9…) Trident Hemispherical Shells (K013676) Tritanium Acetabular Shell System (K081171) Accolade II Femoral Stem (K120578) Secur-Fit Advanced Stem (K122853) Anato Hip Stem (K123604) Device Description: The devices covered by this submission include Stryker Orthopaedics Acetabular Shells, Femoral Stems and T… | 2013 |
What descends from it? (21)
See all 212 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2017 | Class II | Z-0940-2018 | Process control | Inner and outer sterile barriers not fully sealed. |
| Jul 21, 2017 | Class II | Z-0941-2018 | Process control | Inner and outer sterile barriers not fully sealed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 17 of the 39 ancestors have a recall of any class.
- Of its descendants, K153345 (Stryker Orthopaedics, 2016) has gone furthest, with 17 descendants of its own.
- 9 other devices also cite its predicate K983382.
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. 2015, 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 (571 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.
The Trident shells are intended for cementless fixation within the prepared acetabulum.
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.
The Tritanium Acetabular Shell System is intended for cementless use only.
The indications for use for total hip arthroplasty with stems include:
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 indication specific to use of the Accolade II Femoral Stem with compatible Howmedica Osteonics Constrained Liners:
When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty.
The indications for use for total hip arthroplasty with stems include:
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 indication specific to use of Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners:
When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
The indications for use for total hip arthroplasty with stems include:
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 indication specific to use of Anato Hip Stem with compatible Howmedica Osteonics Constrained Liners:
When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
The Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143085
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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