510(k) · Cleared
ClearedKlassic HD Acetabular Insert with E-Link Poly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Joint Orthopedics, Inc. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Oct 9, 2014 as substantially equivalent to K100445 (Total Joint Orthopedics, Inc., 2010) and 2 other predicates after an 80-day review. Its family tree reaches back 9 generations to 1981. 14 later devices descend from it.
- Decided
- Oct 9, 2014
- Review
- 80 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K810258 (1981). 121 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- This deviceK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD®…Total Joint Orthopedics, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · cites it directly · 5 of its ownK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 1 generation backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- This deviceK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc. · 2017 · cites it directly6descendants
- K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016 · cites it directly6descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · cites it directly5descendants
- K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018 · cites it directly5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −2 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −1 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| 0 (this device) | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| +1 | K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low… | Total Joint Orthopedics, Inc. | 2017 | — |
| +1 | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
| +1 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +1 | K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018 | — |
| +2 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 17 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 OQG? 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 OQG device
- #1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 10 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 |
|---|---|---|---|
| * | K100445 | Klassic HD Hip SystemSummary page 5…ETABULAR INSERT WITH E-LINK ' POLY 510(k) PREMARKET NOTIFICATION 510(k) SUMMARY K141972 (pg 2/3) PREDICATE DEVICE(S) e Total Joint Orthopedics Klassic HD" Hip System (K100445) e Pipeline Orthopedics Acetabular Liner with Vitamin E Poly (K112802) o StelKast EXp Acetabular Shell Liner (K094035) INTENDED… | 2010 |
| * | K112802 | Pipeline Total Hip SystemSummary page 5…k) SUMMARY K141972 (pg 2/3) PREDICATE DEVICE(S) e Total Joint Orthopedics Klassic HD" Hip System (K100445) e Pipeline Orthopedics Acetabular Liner with Vitamin E Poly (K112802) o StelKast EXp Acetabular Shell Liner (K094035) INTENDED USE The Klassic HD" Acetabular Insert with E-Link” Poly is intended… | 2012 |
| * | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMSummary page 5…e Total Joint Orthopedics Klassic HD" Hip System (K100445) e Pipeline Orthopedics Acetabular Liner with Vitamin E Poly (K112802) o StelKast EXp Acetabular Shell Liner (K094035) INTENDED USE The Klassic HD" Acetabular Insert with E-Link” Poly is intended for use with the Klassic HD"" Hip System. The Kla… | 2011 |
What descends from it? (14)
See all 145 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 33 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 21 of the 121 ancestors have a recall of any class.
- Of its descendants, K173104 (Total Joint Orthopedics, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K100445.
How does its category compare?
All OQG devicesOQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OQG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OQG
99in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQG
16in 2025
MAUDE reports naming product code OQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 144 | 0 | 0 |
| 2013 | 3 | 280 | 1 | 5 |
| 2014 | 3 | 99 | 0 | 31 |
| 2015 | 1 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 3 | 99 | 0 | 27 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 104 |
| 2020 | 2 | — | 0 | 178 |
| 2021 | 2 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Klassic HD™ Acetabular Insert with E-Link™ Poly, for use within the Klassic HD™ Hip System, is intended for prosthetic replacement without bone cement in treatment of the following:
Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity or dysfunction persists.
Revision of a previously failed hip arthroplasty.
Patients who require a total hip replacement.
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/K141972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141972: Klassic HD Acetabular Insert with E-Link Poly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141972
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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