510(k) · Cleared
ClearedRigi-Fix Hip Stem System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implants Intl., Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 19, 2007 as substantially equivalent to K921301 (Biomet, Inc., 1994) and 1 other predicate after a 111-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Nov 19, 2007
- Review
- 111 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P960047 (1997). 25 ancestors in all, the oldest K830313 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 3 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
- 2 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
- 1 generation backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- This deviceK072101 Rigi-Fix Hip Stem SystemImplants Intl., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −3 | K021728 | Ringloc Constrained Liners II | Biomet, Inc. | 2002 | — |
| −2 | K030047 | Freedom Constrained Liners | Biomet, Inc. | 2003 | — |
| −1 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| 0 (this device) | K072101 | Rigi-Fix Hip Stem System | Implants Intl., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921301 | Taperloc Femoral Stem and Universal Acetabular ComSummary page 1…cup, systems in design, materials and intended use. Equivalent devices include the: BIOMET TAPERLOC Femoral Stem (K921301 S/E 2/16/94 and K043537 S/E 1/14/05) Indications: The RIGI-FIXTM Hip Stern System is… | 1994 |
| * | K043537 | Taperloc 12/14 Taper Femoral ComponentsSummary page 1…use. Equivalent devices include the: BIOMET TAPERLOC Femoral Stem (K921301 S/E 2/16/94 and K043537 S/E 1/14/05) Indications: The RIGI-FIXTM Hip Stern System is intended for uncemented use for… | 2005 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 13 other devices also cite its predicate K921301.
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. 2007, 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?
The RIGI-FIXTM Hip Stem System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to femoral hip stem revisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072101: Rigi-Fix Hip Stem System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072101
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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