510(k) · Cleared
ClearedUnisyn HA Plasma Modular Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hayes Medical, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Dec 21, 2006 as substantially equivalent to K003649 (Hayes Medical, Inc., 2001) and 3 other predicates after a 128-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Dec 21, 2006
- Review
- 128 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921308 (1994). 20 ancestors in all, the oldest K921274 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 4 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 3 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 2 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- This deviceK062383 Unisyn HA Plasma Modular HipHayes Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK120595 Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −4 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −3 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −1 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| 0 (this device) | K062383 | Unisyn HA Plasma Modular Hip | Hayes Medical, Inc. | 2006 | — |
| +1 | K120595 | Unisyn Plus Hip Stem | Consensus Orthopedics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K003649 | Triton Hip SystemSummary page 1…Class 11 Device Classification Panel: Orthopaedic Substantially Equivalent To: Hayes Medical Unisyn Modular Hip System (K003649) Hayes Medical HA Coated Consensus Hip System (K935453)… | 2001 |
| * | K935453 | Consensus (TM) Hip System-HA Coated Tianium Fem StemSummary page 1…uivalent To: Hayes Medical Unisyn Modular Hip System (K003649) Hayes Medical HA Coated Consensus Hip System (K935453) Howmedica/Osteonics, Restoration Modular System… | 1994 |
| * | K022549 | Restoration Modular SystemSummary page 1…Consensus Hip System (K935453) Howmedica/Osteonics, Restoration Modular System (K022549) Biomet Orthopedics, Inc., HAl Modular Reach Proximal… | 2002 |
| * | K022463 | HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral…Summary page 1…(K022549) Biomet Orthopedics, Inc., HAl Modular Reach Proximal Porous (K022463) Intended Use: Indications for use of the UNISYVNT m HIP SYSTEM A) Significantly impaired joints resulting from rheumatoid, osteo… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120595 | Unisyn Plus Hip Stem | 2012 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 9 of the 20 ancestors have a recall of any class.
- Of its descendants, K120595 (Consensus Orthopedics, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K003649.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for use of the UNISYN TM HIP SYSTEM
A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plane, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062383: Unisyn HA Plasma Modular Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062383
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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