510(k) · Cleared
ClearedProform HA Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast Company · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Mar 9, 1994 after a 194-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Mar 9, 1994
- Review
- 194 days
- Class
- Class II
- Product code
- JDO
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 1 citing it directly.
- This deviceK934162 Proform HA Hip SystemStelkast Company · 1994
- Descendant · cites it directly · 28 of its ownK073068 Accin Hip SystemAccelerated Innovation, LLC · 2008
- Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · 3 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
- Descendant · 3 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K073068Accin Hip SystemAccelerated Innovation, LLC · 2008 · cites it directly28descendants
- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
- K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 3 generations on16descendants
- K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 3 generations on14descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934162 | Proform HA Hip System | Stelkast Company | 1994 | — |
| +1 | K073068 | Accin Hip System | Accelerated Innovation, LLC | 2008 | — |
| +2 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +3 | K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014 | — |
| +3 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| +4 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDO? 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 JDO device
- #1 K213126 Smith & Nephew, Inc. Plates and Screws…score 12.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073068 | Accin Hip System | 2008 | 28 |
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?
- Of its descendants, K073068 (Accelerated Innovation, LLC, 2008) has gone furthest, with 28 descendants of its own.
How does its category compare?
All JDO devicesJDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JDO
Too few JDO 510(k)s in any year since 2007 to give a median.
Recalls per year · JDO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDO
1in 2025
MAUDE reports naming product code JDO, 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 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 52 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 1 | — | 0 | 44 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K934162 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934162: Proform HA Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934162
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026