510(k) · Cleared
ClearedNovohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novosource, Inc. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Jun 27, 2014 as substantially equivalent to K132158 (Novosource, Inc., 2014) and 3 other predicates after a 99-day review. Its family tree reaches back 9 generations to 1981. 2 later devices descend from it.
- Decided
- Jun 27, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K810258 (1981). 73 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 1 generation backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- This deviceK140701 Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK151424 The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK192450 Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC · 2019
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 backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 1 generation backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- This deviceK140701 Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −2 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −1 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| 0 (this device) | K140701 | Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug | Novosource, Inc. | 2014 | — |
| +1 | K151424 | The Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | 2016 | — |
| +2 | K192450 | Precision Casting Solutions Total Hip System | Precision Casting Solution, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 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 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? (4)
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 |
|---|---|---|---|
| * | K132158 | Novohip Total Hip SystemSummary page 1…CFR 888.3353 Device Produce Codle(s): OQG, LPH, 120 Predicate Devices: NovoHip Total Hip System (K132158) Zimmer Vivacit-E Vitamin E Highly Crosslinked Polye… | 2014 |
| * | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersSummary page 1…otal Hip System (K132158) Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370) OePuy Pinnacle Acetabular System (K001534) Wright… | 2012 |
| * | K001534 | Pinnacle Acetabular SystemSummary page 1…Vitamin E Highly Crosslinked Polyethylene Liners (K120370) OePuy Pinnacle Acetabular System (K001534) Wright Medical Lineage Acetabular System (K002149) NovoSource K14O7O1ISOOI === Page 2… | 2000 |
| * | K002149 | Lineage Acetabular SystemSummary page 1…20370) OePuy Pinnacle Acetabular System (K001534) Wright Medical Lineage Acetabular System (K002149) NovoSource K14O7O1ISOOI 510(k) Summary K 140701 (pg… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151424 | The Progressive Orthopaedic Total Hip System | 2016 | 1 |
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 2.1 years on median.
- 20 of the 73 ancestors have a recall of any class.
- Of its descendants, K151424 (The Progressive Orthopaedic Company, LLC, 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K132158.
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?
NovoHip Vitamnin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovaSource hip implant components arc indicated for use in cenientless reconstruction of the articulating surface of femoral and/or aectabular portions of the hip that are severely disabled and/or very painful as a result of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis or traumatic arthritis…
Read the full statement (109 words)
NovoHip Vitamnin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovaSource hip implant components arc indicated for use in cenientless reconstruction of the articulating surface of femoral and/or aectabular portions of the hip that are severely disabled and/or very painful as a result of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis or traumatic arthritis
- Correction of functional dcformiy
- Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140701: Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140701
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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