510(k) Report

510(k) · Cleared

Cleared

Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head

K191708510(k) TraditionalCleared Aug 14, 2020415-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Signature Orthopaedics Pty, Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Aug 14, 2020 as substantially equivalent to K161155 (Signature Orthopaedics Pty, Ltd., 2016) and 13 other predicates after a 415-day review. Its family tree reaches back 11 generations to 1981.

Decided
Aug 14, 2020
Review
415 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
14

Its longest line of descent runs back 11 generations to K810258 (1981). 208 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 1 other ancestor2016: 1 other ancestor2014: 2 other ancestors2013: 1 other ancestor2012: 1 other ancestor2008: 5 other ancestors2007: 6 other ancestors2003: 7 other ancestors1998: 11 other ancestors1995: 18 other ancestors2017: 1 other ancestor2010: 5 other ancestors2009: 5 other ancestors2006: 2 other ancestors2005: 9 other ancestors2004: 6 other ancestors2002: 9 other ancestors2001: 9 other ancestors2000: 19 other ancestors1997: 8 other ancestors1996: 13 other ancestors1994: 26 other ancestors1981: 1 other ancestor1979: 1 other ancestor2011: 1 other ancestor1999: 7 other ancestors1991: 3 other ancestors1989: 1 other ancestor1987: 1 other ancestor1983: 1 other ancestor1993: 6 other ancestors1986: 2 other ancestors1992: 5 other ancestors1985: 2 other ancestors1990: 1 other ancestorK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K082996 · Biolox Delta Option Ceramic Heads · Biomet, Inc. · 2009 · recalledK093549 · 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum · Biomet Manufacturing Corp · 2009K121874 · G7 Acetabular System · Biomet Manufacturing Corp · 2012 · recalledK190057 · DJO Acetabular System · Encore Medical L.P. · 2019 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 13 other ancestors2 generations back: 31 other ancestors3 generations back: 49 other ancestors4 generations back: 49 other ancestors5 generations back: 42 other ancestors6 generations back: 13 other ancestors K190057 · DJO Acetabular System · Encore Medical L.P. · 2019 · recalledK121874 · G7 Acetabular System · Biomet Manufacturing Corp · 2012 · recalledK093549 · 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum · Biomet Manufacturing Corp · 2009K082996 · Biolox Delta Option Ceramic Heads · Biomet, Inc. · 2009 · recalledK073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 7 generations between
  3. 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  4. 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  5. 1 generation backK190057 DJO Acetabular SystemEncore Medical L.P. · 2019 · Recalled
  6. This deviceK191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral…Signature Orthopaedics Pty, Ltd. · 2020
Show all 11 generations
  1. Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 4 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
  9. 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  10. 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  11. 1 generation backK190057 DJO Acetabular SystemEncore Medical L.P. · 2019 · Recalled
  12. This deviceK191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral…Signature Orthopaedics Pty, Ltd. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−10K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−9K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−8K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−7K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−6K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−5K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−4K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.20094
−3K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M…Biomet Manufacturing Corp2009—
−2K121874G7 Acetabular SystemBiomet Manufacturing Corp20123
−1K190057DJO Acetabular SystemEncore Medical L.P.20195
0 (this device)K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198110
198310
198520
198620
198710
198910
199010
199130
199250
199360
1994260
1995180
1996130
199780
1998110
199970
2000190
200190
200290
200370
200460
200590
200620
200760
200850
200950
201050
201110
201210
201310
201420
201610
201710
201810
FIG. 1 — Lineage of K191708, 1981–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (14)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K161155Origin Coxa Vara Hip Stem
Summary page 5
…Signature Orthopaedics Pty Ltd Primary Predicate: • Signature Orthopaedics Origin Coxa Vara hip stem (K161155) Secondary Predicate: • 40 – 42mm BiPolar Head and 22mm Femoral Head (K163081)…
Signature Orthopaedics Pty, Ltd.20161
*K16308140-42mm BiPolar Head and 22mm Femoral Head
Summary page 5
…re Orthopaedics Origin Coxa Vara hip stem (K161155) Secondary Predicate: • 40 – 42mm BiPolar Head and 22mm Femoral Head (K163081) • Signature Orthopaedics Origin hip stem (K121297) • Signature Orthopaedic…
Signature Orthopaedics Pty, Ltd.2018—
*K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…
Summary page 5
…dary Predicate: • 40 – 42mm BiPolar Head and 22mm Femoral Head (K163081) • Signature Orthopaedics Origin hip stem (K121297) • Signature Orthopaedics Aria hip stem (K121297) • Signature Orthopaedics…
Signature Orthopaedics Pty, Ltd.20122
*K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…
Summary page 5
…a hip stem (K121297) • Signature Orthopaedics CoCr femoral head (K121297) • Signature Orthopaedics Remedy hip stem (K133370) • Signature Orthopaedics Evolve hip stem (K133370) • FMP Constrained Liner…
Signature Orthopaedics Pty Limited2014—
*K023794Constrained Liner
Summary page 5
…Orthopaedics Remedy hip stem (K133370) • Signature Orthopaedics Evolve hip stem (K133370) • FMP Constrained Liners (K023794) • X-alt HXL Poly Liners (K072154) • X-alt Highly Cross Linked Acetabular L…
Encore Medical L.P.2003—
*K072154Foundation (FMP) Porous Coated Spiked Acetabular System
Summary page 5
…• Signature Orthopaedics Evolve hip stem (K133370) • FMP Constrained Liners (K023794) • X-alt HXL Poly Liners (K072154) • X-alt Highly Cross Linked Acetabular Liner with Vitamin E (K130365 & K…
Encore Medical L.P.20071
*K130365X-Alt Highly Cross Linked VE Acetabular Liner
Summary page 5
…• X-alt HXL Poly Liners (K072154) • X-alt Highly Cross Linked Acetabular Liner with Vitamin E (K130365 & K140130) • Foundation Porous Coated Hemispherical Acetabular Cup…
Encore Medical L.P.2013—
*K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…
Summary page 5
…• X-alt HXL Poly Liners (K072154) • X-alt Highly Cross Linked Acetabular Liner with Vitamin E (K130365 & K140130) • Foundation Porous Coated Hemispherical Acetabular Cup (K9…
Encore Medical L.P.2014—
*K974093Foundation Porous Coated Hemispherical Shell
Summary page 5
…(K130365 & K140130) • Foundation Porous Coated Hemispherical Acetabular Cup (K974093) • FMP Hemispherical Shells (K974093) • Foundation Porous Coated Flared Rim…
Encore Orthopedics, Inc.1998—
*K974095Foundation Porous Coated Flared Rim Shell
Summary page 5
…(K974093) • FMP Hemispherical Shells (K974093) • Foundation Porous Coated Flared Rim Acetabular Cup (K974095) • Foundation Porous Acetabular System (K973119) • EMPOWR Acetabular System…
Encore Orthopedics, Inc.1998—
*K973119Foundation Porous Acetabular System
Summary page 5
…lls (K974093) • Foundation Porous Coated Flared Rim Acetabular Cup (K974095) • Foundation Porous Acetabular System (K973119) • EMPOWR Acetabular System, Cup (K190057) • EMPOWR Acetabular System, Line…
Encore Orthopedics, Inc.1998—
*K190057DJO Acetabular System
Summary page 5
…lared Rim Acetabular Cup (K974095) • Foundation Porous Acetabular System (K973119) • EMPOWR Acetabular System, Cup (K190057) • EMPOWR Acetabular System, Liner (K190057) • Biolox Ceramic Femoral Head…
Encore Medical L.P.20195
*K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve
Summary page 5
…EMPOWR Acetabular System, Cup (K190057) • EMPOWR Acetabular System, Liner (K190057) • Biolox Ceramic Femoral Head (K082844) • Encore Medical BiPolar Head (K953510) Device Description: The purpose of this 510(k) application…
Encore Medical L.P.20081
*K953510Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis
Summary page 5
…EMPOWR Acetabular System, Liner (K190057) • Biolox Ceramic Femoral Head (K082844) • Encore Medical BiPolar Head (K953510) Device Description: The purpose of this 510(k) application is to extend the compatibility of the subject devices between Sig…
Encore Orthopedics, Inc.199518

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 39 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 58 of the 208 ancestors have a recall of any class.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treaent, the devices are indicated for: * Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis * Inflammatory joint disease including rheumatoid arthritis * Correction of functional deformity…

Read the full statement (267 words)

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treaent, the devices are indicated for:

* Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis

* Inflammatory joint disease including rheumatoid arthritis

* Correction of functional deformity including congenital hip dysplasia

* Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture

* Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics’ Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics’ Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics’ Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

* Acute femoral head or neck fracture

* Fracture dislocation of the hip

* Avascular necrosis of the femoral head

* Non-union of femoral neck fractures

* Certain high subcapital and femoral neck fractures in the elderly

* Degenerative arthritis involving only the femoral head

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Signature Orthopaedics Pty, Ltd.

44 FDA decisions under this applicant name. See the company

  • K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd. · 2026
  • K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd. · 2025
  • K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
  • K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd. · 2025
  • K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd. · 2025

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K191708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191708: Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191708

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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