510(k) Report

510(k) · Cleared

Cleared

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

K240783510(k) TraditionalCleared Oct 21, 2024214-day reviewClass II21 CFR 888.3350

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

Smith & Nephew, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Oct 21, 2024 as substantially equivalent to K052792 (Smith & Nephew, Inc., 2005) and 13 other predicates after a 214-day review. Its family tree reaches back 10 generations to 1981.

Decided
Oct 21, 2024
Review
214 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
14

Its longest line of descent runs back 10 generations to K810258 (1981). 179 ancestors in all, the oldest K791125 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 7 other ancestors2009: 5 other ancestors2008: 5 other ancestors2007: 5 other ancestors2005: 9 other ancestors2002: 11 other ancestors1999: 7 other ancestors1997: 11 other ancestors1996: 12 other ancestors1983: 4 other ancestors2018: 2 other ancestors2017: 3 other ancestors2016: 1 other ancestor2015: 3 other ancestors2013: 1 other ancestor2011: 4 other ancestors2010: 3 other ancestors2006: 7 other ancestors2004: 4 other ancestors2003: 4 other ancestors2000: 9 other ancestors1994: 15 other ancestors1993: 3 other ancestors1992: 6 other ancestors1990: 4 other ancestors1979: 1 other ancestor2001: 2 other ancestors1998: 5 other ancestors1991: 3 other ancestors1988: 1 other ancestor1986: 1 other ancestor1985: 2 other ancestors1995: 6 other ancestors1984: 1 other ancestor1987: 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. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K211176 · Smith & Nephew Hip Systems · Smith & Nephew, Inc. · 2022 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 13 other ancestors2 generations back: 57 other ancestors3 generations back: 32 other ancestors4 generations back: 24 other ancestors5 generations back: 23 other ancestors6 generations back: 10 other ancestors7 generations back: 7 other ancestors8 generations back: 2 other ancestors K211176 · Smith & Nephew Hip Systems · Smith & Nephew, Inc. · 2022 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 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 · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  4. 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  5. 1 generation backK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
  6. This deviceK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 4 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 3 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 2 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 1 generation backK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
  11. This deviceK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−6K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−4K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−3K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−2K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20221
0 (this device)K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners…Smith & Nephew, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198340
198410
198520
198610
198710
198810
199040
199130
199260
199330
1994150
199560
1996120
1997110
199850
199970
200090
200120
2002110
200340
200440
200590
200670
200750
200850
200950
201030
201140
201270
201310
201530
201610
201730
201820
FIG. 1 — Lineage of K240783, 1981–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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
*K052792Anthology Hip Stem
Summary page 8
…r Description Number Date Smith & Nephew, Anthology Hip Stems K052792 10/07/2005 Inc. Smith & Nephew, Global Taper Spectron Hip Stems K970351 02/28/1997 Inc. Smi…
Smith & Nephew, Inc.20051
*K970351Global Taper Spectron Hip Stems
Summary page 8
…Nephew, Anthology Hip Stems K052792 10/07/2005 Inc. Smith & Nephew, Global Taper Spectron Hip Stems K970351 02/28/1997 Inc. Smith & Nephew, Global Taper Tapered Hip System,…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K963509Global Taper Tapered Hip System, GT Spectron
Summary page 8
…per Spectron Hip Stems K970351 02/28/1997 Inc. Smith & Nephew, Global Taper Tapered Hip System, K963509 01/27/1997 Inc. GT Spectron Smith & Nephew, R3 Multi-Hole Shells and 36mm…
Smith & Nephew Richards, Inc.1997—
*K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners
Summary page 8
…K963509 01/27/1997 Inc. GT Spectron Smith & Nephew, R3 Multi-Hole Shells and 36mm K092386 11/03/2009 Inc. XLPE Acetabular Liners Smith & Nephew, R3 XLPE Liners…
Smith & Nephew, Inc.2009—
*K113848R3 Xlpe Liners
Summary page 8
…K092386 11/03/2009 Inc. XLPE Acetabular Liners Smith & Nephew, R3 XLPE Liners K113848 04/27/2012 Inc. Smith & Nephew, Reflection 3 Acetabular System K070756 06/06/2007 Inc.…
Smith & Nephew, Inc.20122
*K070756Smith and Nephew Reflection 3 Acetabular System
Summary page 8
…Nephew, R3 XLPE Liners K113848 04/27/2012 Inc. Smith & Nephew, Reflection 3 Acetabular System K070756 06/06/2007 Inc. Porous and Non-Porous Revision Smith & Nephew, Hip Stems of the Revision Hip…
Smith & Nephew, Inc.20076
*K963486Revision Hip System
Summary page 8
…007 Inc. Porous and Non-Porous Revision Smith & Nephew, Hip Stems of the Revision Hip K963486 11/27/1996 Inc System and Heads with Global Taper Smith & Nephew,…
Smith & Nephew Richards, Inc.1996—
*K211176Smith & Nephew Hip Systems
Summary page 8
…6 11/27/1996 Inc System and Heads with Global Taper Smith & Nephew, Smith & Nephew Hip Systems K211176 07/01/2022 Inc. Smith & Nephew, Smith & Nephew MDF Revision Hip…
Smith & Nephew, Inc.20221
*K081124MDF Revision Hip System
Summary page 8
…Nephew Hip Systems K211176 07/01/2022 Inc. Smith & Nephew, Smith & Nephew MDF Revision Hip K081124 07/31/2008 Inc. System Smith & Nephew, Spectron Extra-Small Straight…
Smith & Nephew, Inc.20082
*K831884Spectron Extra-Small, Straight Femoral
Summary page 8
…K081124 07/31/2008 Inc. System Smith & Nephew, Spectron Extra-Small Straight K831884 09/20/1983 Inc. Femoral Prosthesis Smith & Nephew, Spectron Long, Straight Femoral…
Richards Manufacturer Co.1983—
*K823722Spectron Long, Straight Femoral Prosthes
Summary page 8
…4 09/20/1983 Inc. Femoral Prosthesis Smith & Nephew, Spectron Long, Straight Femoral K823722 03/08/1983 Inc. Prosthesis Smith & Nephew, Synergy Cemented Hip Stem K99036…
Richard'S Medical Equip., Inc.1983—
*K990369Synergy Cemented Hip Stem
Summary page 8
…K823722 03/08/1983 Inc. Prosthesis Smith & Nephew, Synergy Cemented Hip Stem K990369 03/12/1999 Inc. Smith & Nephew, Synergy Porous Size 8 Hip Stem K991485 07/12/1999 Inc. Smi…
Smith & Nephew, Inc.1999—
*K991485Synergy Porous Size 8 Hip Stem
Summary page 8
…Nephew, Synergy Cemented Hip Stem K990369 03/12/1999 Inc. Smith & Nephew, Synergy Porous Size 8 Hip Stem K991485 07/12/1999 Inc. Smith & Nephew, Total Hip Femoral Heads – 12/14…
Smith & Nephew, Inc.1999—
*K021673Total Hip Femoral Head - 12/14 Taper
Summary page 8
…Porous Size 8 Hip Stem K991485 07/12/1999 Inc. Smith & Nephew, Total Hip Femoral Heads – 12/14 K021673 06/11/2002 Inc. Taper Device Description: The purpose of this Traditional 510(k) is the following: 1.…
Smith & Nephew, Inc.20021

Also cleared against K052792: 18 other devices →

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 43 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 44 of the 178 ancestors have a recall of any class.
  • 18 other devices also cite its predicate K052792.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for…

Read the full statement (503 words)

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) with bone cement, (ii) without bone cement, or (iii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.

Some of the diagnoses listed above may increase risk of complications and reduce the chance of a satisfactory result. Specifically, an increased risk of complications for revision surgery for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level can negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a high likelihood of revision in younger, heavier, or more active patients. Specifically, the risk of complications is greater in obese and morbidly obese patients.

The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.

The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

Acetabular Hip Components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The Constrained Liners are indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

Some of the diagnoses listed above are associated with an increased risk of complications and reduced chance of a satisfactory short- and long-term outcomes. Specifically, an increased risk of complications to revision surgeries for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level may negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a higher likelihood of revision in younger, heavier and/or more active patients. Specifically, the risk of complications is higher in obese patients.

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

Also cleared against K052792

18 other devices cite the same predicate.

  • K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025
  • K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024
  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 20221 recall
  • K173267MasterLoc Stem: Lateralized PlusMedacta International S.A. · 2017
  • K172684Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip StemSmith & Nephew, Inc. · 2017
  • K131022Ovation 10/12 Hip StemOrtho Development Corp. · 2013

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
  • K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K240783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240783

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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