510(k) · Cleared
ClearedMinihip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 5, 2010 as substantially equivalent to K051738 (Howmedica Osteonics Corp., 2005) and 3 other predicates after a 511-day review. Its family tree reaches back 8 generations to 1996. 15 later devices descend from it.
- Decided
- Apr 5, 2010
- Review
- 511 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K955033 (1996). 82 ancestors in all, the oldest K840643 (1984). 15 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 7 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 6 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 5 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 4 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 3 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 2 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 1 generation backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- This deviceK083312 Minihip StemCorin USA · 2010
- Descendant · cites it directly · 8 of its ownK103518 Trinity Acetabular SystemCorin USA · 2011
- Descendant · 2 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 3 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · cites it directly · 3 of its ownK131986 Corin Minihip StemCorin USA · 2013
- Descendant · 3 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K103518Trinity Acetabular SystemCorin USA · 2011 · cites it directly8descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 2 generations on7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 3 generations on3descendants
- K131986Corin Minihip StemCorin USA · 2013 · cites it directly3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −7 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −6 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −5 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −4 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −3 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −1 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| 0 (this device) | K083312 | Minihip Stem | Corin USA | 2010 | — |
| +1 | K103518 | Trinity Acetabular System | Corin USA | 2011 | — |
| +2 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +3 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +1 | K131986 | Corin Minihip Stem | Corin USA | 2013 | — |
| +3 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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 |
|---|---|---|---|
| * | K051738 | Secur-Fit Max and Plus Max Hip StemsSummary page 2…proximal coating of plasma-sprayed HA over plasma-sprayed titanium is the equivalent to that applied to the Secur-Fit Max Hip and Secur-Fit Plus Max Hip Stems (K05 1738). Based on these similarities, Corin believes that the MiniHip Hip Stem is substantially equivalent to the predic… | 2005 |
| * | K080584 | Metha Short Stem Hip SystemSummary page 1…wmedica Osteonics Secur-Fit Max Hip and Secure-Fit Plus Max Hip Stems (KO5 1738) b. Aesculap Implant Systems NMetha Short Stem Hip System (K080584) c. Zimmer MAYO Conservative Hip Prosthesis (K030733) d. Smith & Nephew MIS Hip Stem (K0724 17) 7.… | 2008 |
| * | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 SeriesSummary page 1…ms (KO5 1738) b. Aesculap Implant Systems NMetha Short Stem Hip System (K080584) c. Zimmer MAYO Conservative Hip Prosthesis (K030733) d. Smith & Nephew MIS Hip Stem (K0724 17) 7. Device Description: The MiniHip Stem is a titanium fe… | 2003 |
| * | K072417 | Smith & Nephew Mis Hip StemSummary page 1…p Implant Systems NMetha Short Stem Hip System (K080584) c. Zimmer MAYO Conservative Hip Prosthesis (K030733) d. Smith & Nephew MIS Hip Stem (K0724 17) 7. Device Description: The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion… | 2008 |
What descends from it? (15)
See all 154 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?
- The line of descent spans 14 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 23 of the 81 ancestors have a recall of any class.
- Of its descendants, K103518 (Corin USA, 2011) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K051738.
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. 2010, this device’s year, is highlighted.
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 indications for the MiniHip Stem as a total hip arthroplasty include:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
DDH/CDH
Revision procedures where other treatments or devices have failed
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The MiniHip Stem is indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083312: Minihip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083312
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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