510(k) · Cleared
ClearedNatural-Hip System Cocr Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jan 27, 1997 as substantially equivalent to K944209 (Intermedics Orthopedics, 1994) after an 87-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 27, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- LZO
- 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 deviceK964357 Natural-Hip System Cocr StemIntermedics 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) | K964357 | Natural-Hip System Cocr Stem | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 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 |
|---|---|---|---|
| * | 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…eting by the FDA: IOI metallic femoral bearing heads {510(k)s K905781 and K913060], 101 Biolox Bearing Heads [S10(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],… | 1994 |
| * | — | Premier Hip Stem Named without a submission number | |
| * | — | ODC Hip Stem Named without a submission number | |
| * | — | Perfecta IMC Stem 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 LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Narral-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natral-Hip Systern CoCr Stem is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDID), e.g., avascular necrosis, osteoarthritis and inflammatory…
Read the full statement (154 words)
The Narral-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natral-Hip Systern CoCr Stem is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include:
1. Patient conditions of non-inflammatory degenerative joint disease (NIDID), e.g., avascular necrosis, osteoarthritis and inflammatory joint discase (1JD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
3. Revision of previously failed arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading arc assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
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/K964357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964357: Natural-Hip System Cocr Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964357
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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