510(k) · Cleared
ClearedLateralized Intergral Porous Primary Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 18, 1999 as substantially equivalent to K921225 (Biomet, Inc., 1994) after a 79-day review. Its family tree reaches back 1 generation to 1994. 211 later devices descend from it.
- Decided
- Feb 18, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921225 (1994). 211 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK921225 Integral Total Hip SystemBiomet, Inc. · 1994
- This deviceK984296 Lateralized Intergral Porous Primary Femoral ComponentBiomet, Inc. · 1999
- Descendant · cites it directly · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- Descendant · 2 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 211 · See all- K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc. · 2003 · cites it directly208descendants
- K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 2 generations on160descendants
- K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · 2 generations on138descendants
- K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 3 generations on137descendants
- K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · 4 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921225 | Integral Total Hip System | Biomet, Inc. | 1994 | — |
| 0 (this device) | K984296 | Lateralized Intergral Porous Primary Femoral Component | Biomet, Inc. | 1999 | — |
| +1 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| +2 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| +2 | K050124 | Porous Coated Acetabular Components | Biomet, Inc. | 2005 | 1 |
| +3 | K070369 | Regenerx Ringloc + Modular Acetabular Shells | Biomet, Inc. | 2007 | 19 |
| +4 | K093235 | Ringloc + Hybrid Acetabular System | Biomet, Inc. | 2010 | 30 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 15 | 0 |
| 2013 | 10 | 0 |
| 2014 | 16 | 0 |
| 2015 | 11 | 0 |
| 2016 | 9 | 0 |
| 2017 | 12 | 0 |
| 2018 | 7 | 0 |
| 2019 | 21 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 16 | 0 |
| 2026 | 17 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921225 | Integral Total Hip SystemSummary page 2…component on the market today in terms of overall intended function and design. Direct comparison was made with the following predicates: Biomet Integral Primary Porous K921225 Biomet Lateralized Taperloc Hip System K9521301 & % £ % /c % %, *” sll"c.,.b ol DEPARTMENT OF HEALTH & HUMAN… | 1994 |
| Kept off the family tree | K952301 | FDA’s K952301 is Laser Gas Mixture Our OCR of the scanned summary read K952301, FDA’s number for Laser Gas Mixture (Airgas Management, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Biomet Lateralized Taperloc Hip System”. Kept off the family tree. | 1995 |
What descends from it? (211)
See all 2112 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular Necrosis
b.) rheumatoid arthritis
c.) correction of functional deformities
d.) revisions procedures where other devices or treatments have failed
e.) treatment of non-unions, femoral neck trochanteric fractures of the proximal femur with neck involvement, unmanageable using other techniques
The Lateralized Integral Hip Stem is intended for press-fit application and is for single use implantation.
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/K984296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984296: Lateralized Intergral Porous Primary Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984296
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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