510(k) · Cleared
ClearedNatural-Hip System Porous Stem with HA/Csti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 3, 1997 as substantially equivalent to K944209 (Intermedics Orthopedics, 1994) after a 160-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 3, 1997
- Review
- 160 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944209 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944209 Apr II Non Porous Hip StemIntermedics Orthopedics · 1994
- This deviceK970300 Natural-Hip System Porous Stem with HA/CstiIntermedics Orthopedics · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944209 | Apr II Non Porous Hip Stem | Intermedics Orthopedics | 1994 | — |
| 0 (this device) | K970300 | Natural-Hip System Porous Stem with HA/Csti | Intermedics Orthopedics | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K944209 | Apr II Non Porous Hip Stem Our OCR of the scanned summary read “K944209” beside “510(k)”; FDA’s K944209 is the only number that fits it and carries the summary’s name for the device. Summary page 1…cleared devices: IOI metallic femoral bearing heads (510(k)s K905781 and K913060), I0OI Biolox Bearing Heads (510(k)s K923734, K942330), Zirconia Bearing Heads (510(k) K944209), IOI bipolar components (510(k)s K833404 and K873815), IOI unipolar components (510(k)s K833403 and K934159), 000786 === Pag… | 1994 |
| * | — | APR Universal Hip System with Calcitite®-Coated CSTi Named without a submission number | |
| * | — | Howmedica Precision Osteolock Named without a submission number | |
| * | — | Osteonics Omnifit with HA Named without a submission number |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K944209.
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.
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. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IID), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
3. Revision of previously failed arthroplasty.
The Natural-Hip™ System Porous Stem with HA/CSTi™ is intended only for use without bone cement.
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/K970300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970300: Natural-Hip System Porous Stem with HA/Csti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970300
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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