510(k) · Cleared
ClearedTritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 11, 2011 as substantially equivalent to K081171 (Howmedica Osteonics Corp., 2008) and 4 other predicates after a 357-day review. Its family tree reaches back 6 generations to 1996. 22 later devices descend from it.
- Decided
- Apr 11, 2011
- Review
- 357 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K955033 (1996). 64 ancestors in all, the oldest K840643 (1984). 22 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 4 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 3 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 2 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 1 generation backK043079 Bicontact Hip System with U-CapAesculap · 2004
- This deviceK101072 Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium…Howmedica Osteonics Corp. · 2011
- Descendant · cites it directly · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 2 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 3 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 4 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · cites it directly21descendants
- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 2 generations on20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 3 generations on19descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 4 generations on9descendants
- K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −5 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −4 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −3 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −2 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −1 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| 0 (this device) | K101072 | Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite | Howmedica Osteonics Corp. | 2011 | — |
| +1 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +2 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +3 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +4 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +4 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 8 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K081171 | Tritanium Acetabular Shell SystemSummary page 2…. The outer surface of the acetabular shell has the identical geometry as the predicate Tritanium® Acetabular Shell System determined substantially equivalent via 510(k) K08 1171. Intended Use: The Tritaniumo Peri-Apatite m Acetabular Shell is a sterile, single-use device intended for use in primary and re… | 2008 |
| * | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite CoatingSummary page 1…tial Equivalence is Claimed: Howmedica Osteonics Tritaniumn Acetabular Shell System: K08I1171 Howmedica Osteonics Vitalock Solid Back Acetabular Shell with Peri-Apatite: K971206 Landos Inc. Corail Stem: K9531 I11 Aesculap BiContact Hip System with g-CaP? K043079 Smith& Nephew, Smith & Nephew Hip Systems wi… | 1998 |
| * | K953111 | Corail | 1996 |
| * | K043079 | Bicontact Hip System with U-CapSummary page 1…K08I1171 Howmedica Osteonics Vitalock Solid Back Acetabular Shell with Peri-Apatite: K971206 Landos Inc. Corail Stem: K9531 I11 Aesculap BiContact Hip System with g-CaP? K043079 Smith& Nephew, Smith & Nephew Hip Systems with HA Coating: K090982. Device Description: The Tritanium®@ Peri-Apatite Tm acetabul… | 2004 |
| * | K090982 | Smith & Nephew Hip Systems with HA Cleared while this submission was under review Summary page 1…ith Peri-Apatite: K971206 Landos Inc. Corail Stem: K9531 I11 Aesculap BiContact Hip System with g-CaP? K043079 Smith& Nephew, Smith & Nephew Hip Systems with HA Coating: K090982. Device Description: The Tritanium®@ Peri-Apatite Tm acetabular shells are available in both solid backed and cluster screw-hole… | 2010 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122158 | PBP Total Hip System | 2012 | 21 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 22 of the 63 ancestors have a recall of any class.
- Of its descendants, K122158 (Pipeline Biomedical Products, LLC, 2012) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K081171.
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. 2011, 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?
The indications for use of the total hip replacement prostheses include: 1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. 2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less…
Read the full statement (236 words)
The indications for use of the total hip replacement prostheses include:
1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor bone quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Additional indications for use when using constrained liners: The device is indicated for use as a component of a total hip prosthesis 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 intra-operative instability.
Additional indications for use when using modular dual mobility (MDM) liners: The device is indicated for use as a component of a total hip prosthesis and include:
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed;
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and
6. Dislocation risks
The MDM liners are intended for cementless use only. The acetabular shell is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101072: Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101072
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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