510(k) · Cleared
ClearedSummit Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 26, 2018 as substantially equivalent to K001991 (DePuy Orthopaedics, Inc., 2000) and 6 other predicates after a 448-day review. Its family tree reaches back 15 generations to 1994. 27 later devices descend from it.
- Decided
- Apr 26, 2018
- Review
- 448 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K941847 (1994). 182 ancestors in all, the oldest K810258 (1981). 27 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations between
- 3 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 2 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 1 generation backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- This deviceK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- Descendant · cites it directly · 20 of its ownK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- Descendant · 2 generations on · 15 of its ownK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- Descendant · cites it directly · 13 of its ownK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- Descendant · 3 generations on · 7 of its ownK211703 Insignia Hip StemStryker Orthopaedics · 2021
- Descendant · cites it directly · 7 of its ownK211657 EMPHASYS Femoral StemsDepuy Ireland UC · 2021
Show all 15 generations
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 13 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 12 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 11 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 10 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 9 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 8 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 7 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 6 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 5 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 4 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 3 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 2 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 1 generation backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- This deviceK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020 · cites it directly20descendants
- K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020 · 2 generations on15descendants
- K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021 · cites it directly13descendants
- K211703Insignia Hip StemStryker Orthopaedics · 2021 · 3 generations on7descendants
- K211657EMPHASYS Femoral StemsDepuy Ireland UC · 2021 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −14 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −13 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −12 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −11 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −10 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −9 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −8 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −7 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −6 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −5 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −4 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −3 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −2 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −1 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| 0 (this device) | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| +1 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| +2 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| +1 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 | — |
| +3 | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| +1 | K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 12 | 0 |
| 1996 | 12 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 19 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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? (7)
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 |
|---|---|---|---|
| * | K001991 | Titan Porocoat Hip ProsthesisSummary page 4…1 CFR 888.3353, 888.3350, 888.3358, 888.3360, and 888.3390 Product Codes LZO, JDI, LWJ, LPH, MEH, KWY, LZY, KWL K001991 Titan Porocoat Hip Prosthesis K011489 Summit Duofix Hip Prosthesis… | 2000 |
| * | K011489 | Summit Duofix Hip ProsthesisSummary page 4…LZO, JDI, LWJ, LPH, MEH, KWY, LZY, KWL K001991 Titan Porocoat Hip Prosthesis K011489 Summit Duofix Hip Prosthesis K013352 Summit Cemented Hip Prosthesis Predicate Devi… | 2001 |
| * | K013352 | Summit Cemented Hip ProsthesisSummary page 4…K001991 Titan Porocoat Hip Prosthesis K011489 Summit Duofix Hip Prosthesis K013352 Summit Cemented Hip Prosthesis Predicate Devices K023453 DePuy Cemented FX Cemented Hip Prosthesis… | 2001 |
| * | K023453 | Depuy Summit FX Cemented Hip ProsthesisSummary page 4…K011489 Summit Duofix Hip Prosthesis K013352 Summit Cemented Hip Prosthesis Predicate Devices K023453 DePuy Cemented FX Cemented Hip Prosthesis K030122 DePuy Summit Basic Press Fit Hip… | 2002 |
| * | K030122 | Depuy Summit Basic Press-Fit Hip StemSummary page 4…13352 Summit Cemented Hip Prosthesis Predicate Devices K023453 DePuy Cemented FX Cemented Hip Prosthesis K030122 DePuy Summit Basic Press Fit Hip Prosthesis K150862 DePuy Actis DuoFix Hip Prosthe… | 2003 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 4…Puy Cemented FX Cemented Hip Prosthesis K030122 DePuy Summit Basic Press Fit Hip Prosthesis K150862 DePuy Actis DuoFix Hip Prosthesis K123991 DePuy Corail AMT Hip Prosthesis… | 2015 |
| * | K123991 | Depuy Corail Amt Hip ProsthesisSummary page 4…DePuy Summit Basic Press Fit Hip Prosthesis K150862 DePuy Actis DuoFix Hip Prosthesis K123991 DePuy Corail AMT Hip Prosthesis The purpose of this submission is to append to the exist… | 2013 |
What descends from it? (27)
See all 273 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 24 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 44 of the 181 ancestors have a recall of any class.
- Of its descendants, K193398 (DePuy Orthopaedics, Inc., 2020) has gone furthest, with 20 descendants of its own.
- 9 other devices also cite its predicate K001991.
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. 2018, 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?
Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total…
Read the full statement (202 words)
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Hemi hip replacement is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.
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/K170339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170339: Summit Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170339
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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