510(k) · Cleared
Recalled · Class II · 2020Mallory/Head Modular Calcar with and Without HA
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 Aug 6, 2003 as substantially equivalent to K945115 (Biomet, Inc., 1995) and 3 other predicates after a 65-day review. Its family tree reaches back 3 generations to 1994. 39 later devices descend from it. It has been recalled 16 times.
- Decided
- Aug 6, 2003
- Review
- 65 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 16
- Predicates
- 5
Its longest line of descent runs back 3 generations to K921274 (1994). 6 ancestors in all. 39 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921274 Metallic Toatal Hip SystemBiomet, Inc. · 1994
- 2 generations backK994038 Modular Reach HipBiomet, Inc. · 1999
- 1 generation backK022463 HA Modular Reach Proximal Porous and HA Modular Reach Collared…Biomet Orthopedics, Inc. · 2002
- This deviceK031693 Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003
- Descendant · cites it directly · 38 of its ownK042774 Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005
- Descendant · cites it directly · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- Descendant · 3 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 3 generations on · 7 of its ownK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005 · cites it directly38descendants
- K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · cites it directly37descendants
- K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · 2 generations on27descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 3 generations on13descendants
- K151739Revision Femoral StemLima Corporate S.P.A. · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921274 | Metallic Toatal Hip System | Biomet, Inc. | 1994 | — |
| −2 | K994038 | Modular Reach Hip | Biomet, Inc. | 1999 | — |
| −1 | K022463 | HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous… | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K031693 | Mallory/Head Modular Calcar with and Without HA | Biomet, Inc. | 2003 | — |
| +1 | K042774 | Mallory-Head Modular Calcar Stems with Interlocking Slots | Biomet, Inc. | 2005 | — |
| +1 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| +2 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| +3 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +3 | K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 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 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? (5)
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 |
|---|---|---|---|
| * | K945115 | Mallory-Head Modular Calcar Repacement ComponentsSummary page 1…zemerited prosthesis (21 CFR 888.3358) LEgally Marketed Devices To Which Substantial Equivalence Is Claimed: M;illory--lead Modular Calcar Replacement Components, 510(k)K945115 M8illory-dead Modular Calcar Total Hip with Roller- Hardened/Machined Tapers, 51O(k) K(1003315 Tt e Reach@ Femoral Component, 51O… | 1995 |
| Kept off the family tree | K003315 | FDA’s K003315 is Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner… Our reading of the summary gave K003315, FDA’s number for Shiley Tracheosoft XLT Extended Length Tracheostomy Tube… (Mallinckrodt, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mallory-Head Modular Calcar Total Hip with Roller-Hardened/Machined…”. Kept off the family tree. Summary page 1…e Is Claimed: M;illory--lead Modular Calcar Replacement Components, 510(k)K945115 M8illory-dead Modular Calcar Total Hip with Roller- Hardened/Machined Tapers, 51O(k) K(1003315 Tt e Reach@ Femoral Component, 51O(k) KO00760 M 4lory-Head Modular Calcar (I 00% porous stems), 51O(… | 2000 |
| * | K000760 | Reach Femoral Component | 2000 |
| * | K001660 | Mallory Head Modular Calcar | 2000 |
| * | K022463 | HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral… | 2002 |
What descends from it? (39)
See all 392 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2020 | Class II | Z-0622-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Mar 10, 2010 | Not classified | Z-1672-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1671-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1679-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1667-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1670-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1673-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1666-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1669-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1665-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1677-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1668-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1676-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1674-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1678-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Mar 10, 2010 | Not classified | Z-1675-2010 | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K042774 (Biomet, Inc., 2005) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K945115.
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?
Cemented and non-cemented total joint replacement in cases of:
1) Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis
2) Rheumatoid arthritis
3) Correction of functional deformity
4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5) Revision of previously failed total hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031693: Mallory/Head Modular Calcar with and Without HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031693
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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