510(k) · Cleared
ClearedProvident II Hip Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 14, 2021 as substantially equivalent to K190276 (Stelkast, Inc., 2019) and 1 other predicate after a 384-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Jul 14, 2021
- Review
- 384 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K810258 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 4 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 3 generations backK094035 Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded…Stelkast Company · 2011
- 2 generations backK122773 Cross-Over Acetabular Shell & LinerStelkast Company · 2012 · Recalled
- 1 generation backK190276 Provident II Hip StemStelkast, Inc. · 2019
- This deviceK201733 Provident II Hip StemsGlobus Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −5 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −4 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −3 | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM | Stelkast Company | 2011 | — |
| −2 | K122773 | Cross-Over Acetabular Shell & Liner | Stelkast Company | 2012 | 1 |
| −1 | K190276 | Provident II Hip Stem | Stelkast, Inc. | 2019 | — |
| 0 (this device) | K201733 | Provident II Hip Stems | Globus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 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 24.3 · 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? (2)
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 |
|---|---|---|---|
| * | K190276 | Provident II Hip StemSummary page 4…Product Codes: LPH, JDI, LWJ, LZO, OQH, OQI, KWY Regulatory Class: II, Panel Code: 87 Primary Predicate: Provident II Hip Stem (K190276) Additional Predicate: Provident Hip System (K935484) Purpose: The purpose of this submission is to request clearance for addit… | 2019 |
| * | K935484 | Provident Hip SystemSummary page 4…, OQH, OQI, KWY Regulatory Class: II, Panel Code: 87 Primary Predicate: Provident II Hip Stem (K190276) Additional Predicate: Provident Hip System (K935484) Purpose: The purpose of this submission is to request clearance for additional Provident II Hip Stem implants. Device Descript… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K190276.
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. 2021, 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?
1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Cemented and uncemented applications.
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/K201733 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201733: Provident II Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201733
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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