510(k) · Cleared
ClearedNovation Crown Cup with Integrip Acetabular Shell, Cluster-Hole
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 5, 2010 as substantially equivalent to K070479 (Exactech, Inc., 2007) after a 30-day review. Its family tree reaches back 7 generations to 1994. 53 later devices descend from it.
- Decided
- Nov 5, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931641 (1994). 21 ancestors in all, the oldest K862234 (1986). 53 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 3 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 2 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- 1 generation backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- This deviceK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- Descendant · cites it directly · 36 of its ownK122798 Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012
- Descendant · cites it directly · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 10 of its ownK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · Recalled
- Descendant · 2 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012 · cites it directly36descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · cites it directly35descendants
- K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly12descendants
- K141395Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · 2 generations on10descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −6 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −3 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −2 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| −1 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| 0 (this device) | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| +1 | K122798 | Integrip Acetabular Shell, Integrip Revision Acetabular Shell | Exactech, Inc. | 2012 | — |
| +1 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +1 | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | Lima Corporate S.P.A. | 2012 | — |
| +2 | K141395 | Delta TT Acetabular System | Lima Corporate S.P.A. | 2014 | 1 |
| +2 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K070479 | Exactech Novation Crown Cup and LinersSummary page 1…orous, uncemented. Information on devices to which substantial equivalence is claimed: 510(k) Number Trade of Proprietary Model Name Manufacturer K070479 Novation® Crown CupTm and Liners Exactech, Inc Indications for Use: All Exactech Hip Systems are indi… | 2007 |
| † | K101761 | Exactech Novation Empire Acetabular Augment with Integrip Model 186-01-08/11/13… | 2010 |
What descends from it? (53)
See all 534 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)
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 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K122798 (Exactech, Inc., 2012) has gone furthest, with 36 descendants of its own.
- 5 other devices also cite its predicate K070479.
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. 2010, 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?
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing…
Read the full statement (142 words)
All Exactech Hip Systems are indicated for use in skeletally mature individuals
undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid
arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for
treatment of proximal femoral fractures where prosthetic replacement is determined
by the surgeon as the preferred treatment. Components of Exactech Hip Systems are
also potentially indicated for ankylosing spondylitis, congenital hip dysplasia,
revision of failed previous reconstructions where sufficient bone stock is present, and
to restore mobility resulting from previous fusion.
* Cemented femoral stems and cemented acetabular cups are intended for
cemented fixation only.
* Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
Press-fit components without hydroxyapatite (HA) coating may also be used
with bone cement at the discretion of the surgeon
* Femoral heads and endoprostheses are intended for use in cemented and
press-fit applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102975: Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102975
Report an extraction error
Are you the manufacturer?
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