510(k) · Cleared
Recalled · Class II · 2024Novohip Total Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novosource, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 21, 2014 as substantially equivalent to K935484 (Stelkast Company, 1994) and 3 other predicates after a 224-day review. Its family tree reaches back 8 generations to 1981. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 21, 2014
- Review
- 224 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K810258 (1981). 38 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 4 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 3 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 2 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 1 generation backK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
- This deviceK132158 Novohip Total Hip SystemNovosource, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK143314 Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2015
- Descendant · cites it directly · 2 of its ownK140701 Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK213842 ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK151424 The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK243456 ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2015 · cites it directly2descendants
- K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014 · cites it directly2descendants
- K213842ONVOY Acetabular SystemGlobus Medical, Inc. · 2022 · cites it directly1descendant
- K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016 · 2 generations on1descendant
- K243456ONVOY™ Acetabular SystemGlobus Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −4 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −2 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −1 | K083762 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K132158 | Novohip Total Hip System | Novosource, Inc. | 2014 | — |
| +1 | K143314 | Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | 2015 | — |
| +1 | K140701 | Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug | Novosource, Inc. | 2014 | — |
| +1 | K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022 | — |
| +2 | K151424 | The Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | 2016 | — |
| +2 | K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K935484 | Provident Hip SystemSummary page 1…nonporous uncemented prosthesis per 21 CFR 888.3353 Device Product Code: IPH, 120 Predicate Devices: Stelkast Provident Hip System (K(935484, K(033944) Smith & Nephew Biolox Delta Ceramic Femoral Head (K(083762)… | 1994 |
| * | K033944 | Stelkast 32MM Modular Ceramic Femoral HeadSummary page 1…orous uncemented prosthesis per 21 CFR 888.3353 Device Product Code: IPH, 120 Predicate Devices: Stelkast Provident Hip System (K(935484, K(033944) Smith & Nephew Biolox Delta Ceramic Femoral Head (K(083762)… | 2004 |
| * | K083762 | Biolox Delta Ceramic Femoral HeadsSummary page 1…redicate Devices: Stelkast Provident Hip System (K(935484, K(033944) Smith & Nephew Biolox Delta Ceramic Femoral Head (K(083762) Wright Medical Lineage Acetabular System (K002149) Device Classification: Class 11… | 2009 |
| * | K002149 | Lineage Acetabular SystemSummary page 1…Smith & Nephew Biolox Delta Ceramic Femoral Head (K(083762) Wright Medical Lineage Acetabular System (K002149) Device Classification: Class 11 DEVICE DESCRIPTION The NovoHip Total Hip System isa non-cemented hip prosthesis t… | 2000 |
What descends from it? (6)
3 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 |
|---|---|---|---|---|
| Sep 19, 2024 | Class II | Z-0483-2025 | Mixed-up of materials/components | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted |
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.
- 9 of the 38 ancestors have a recall of any class.
- Of its descendants, K143314 (The Progressive Orthopaedic Company, LLC, 2015) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K935484.
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. 2014, 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?
NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/ar very painful as a result of:
* Non-inflammatory degenerative joint disease including osteoarthritls and avascular necrosis
* Rheumatoid arthritis or traumatic arthritis
* Correction of functional deformity
* 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/K132158 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132158: Novohip Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132158
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