510(k) Report

510(k) · Cleared

Cleared

Betacone Hip Prosthesis System

K051826510(k) TraditionalCleared Nov 18, 2005136-day reviewClass II21 CFR 888.3360

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

Waldemar Link GmbH & Co. KG · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Nov 18, 2005 as substantially equivalent to K930963 (Encore Orthopedics, Inc., 1994) and 4 other predicates after a 136-day review. Its family tree reaches back 4 generations to 1987.

Decided
Nov 18, 2005
Review
136 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K871453 (1987). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2001: 1 other ancestor1994: 1 other ancestorK871453 · Zweymueller-SL Hip Prosthesis Stem · Allo Pro Corp. · 1987K962101 · Zweymueller SL Femoral Hip Stem · Intermedics Orthopedics · 1996K030373 · Alloclassic Zweymueller SL/SLL Femoral Stem · Centerpulse Orthopedics, Inc. · 2003 · recalledK033664 · Modification to Alloclassic Zweymuller SL Offset Femoral Stem · Centerpulse Orthopedics, Inc. · 2003 · recalled19851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors K033664 · Modification to Alloclassic Zweymuller SL Offset Femoral Stem · Centerpulse Orthopedics, Inc. · 2003 · recalledK030373 · Alloclassic Zweymueller SL/SLL Femoral Stem · Centerpulse Orthopedics, Inc. · 2003 · recalledK962101 · Zweymueller SL Femoral Hip Stem · Intermedics Orthopedics · 1996K871453 · Zweymueller-SL Hip Prosthesis Stem · Allo Pro Corp. · 19870
  1. Root · 4 generations backK871453 Zweymueller-SL Hip Prosthesis StemAllo Pro Corp. · 1987
  2. 3 generations backK962101 Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
  3. 2 generations backK030373 Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
  4. 1 generation backK033664 Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc. · 2003 · Recalled
  5. This deviceK051826 Betacone Hip Prosthesis SystemWaldemar Link GmbH & Co. KG · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K871453Zweymueller-SL Hip Prosthesis StemAllo Pro Corp.1987—
−3K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics1996—
−2K030373Alloclassic Zweymueller SL/SLL Femoral StemCenterpulse Orthopedics, Inc.20031
−1K033664Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc.20031
0 (this device)K051826Betacone Hip Prosthesis SystemWaldemar Link GmbH & Co. KG2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200110
200410
FIG. 1 — Lineage of K051826, 1987–2005Source: 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 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K930963SL-Plus & SLR-Plus Stems W/Biolox Ceramic Heads
Summary page 2
…888.3860, LWJ. Nov 17 05 12:30P Predicate Devices Encore Orthopaedics' SL-Plus and SLRt-Plus Stems (Encore) (1K930963); Centerpulse's CLS Spotorno Stems (CLS) (1(042249, K010839); Zinmmer's Alloclassic Femor…
Encore Orthopedics, Inc.1994—
*K042249CLS Spotorno Stem
Summary page 2
…redicate Devices Encore Orthopaedics' SL-Plus and SLRt-Plus Stems (Encore) (1K930963); Centerpulse's CLS Spotorno Stems (CLS) (1(042249, K010839); Zinmmer's Alloclassic Femoral Stems (Alloclassic) (K(033664, K030373). Intended Use I…
Zimmer Austin, Inc.20041
*K010839CLS Varus Stem/CLS 135 Stem
Summary page 2
…Devices Encore Orthopaedics' SL-Plus and SLRt-Plus Stems (Encore) (1K930963); Centerpulse's CLS Spotorno Stems (CLS) (1(042249, K010839); Zinmmer's Alloclassic Femoral Stems (Alloclassic) (K(033664, K030373). Intended Use I Indicati…
Sulzer Orthopedics, Inc.2001—
*K033664Modification to Alloclassic Zweymuller SL Offset Femoral Stem
Summary page 2
…ore) (1K930963); Centerpulse's CLS Spotorno Stems (CLS) (1(042249, K010839); Zinmmer's Alloclassic Femoral Stems (Alloclassic) (K(033664, K030373). Intended Use I Indications for Use The BetaCone is intended for non-cemented use to r…
Centerpulse Orthopedics, Inc.20031
*K030373Alloclassic Zweymueller SL/SLL Femoral Stem
Summary page 2
…930963); Centerpulse's CLS Spotorno Stems (CLS) (1(042249, K010839); Zinmmer's Alloclassic Femoral Stems (Alloclassic) (K(033664, K030373). Intended Use I Indications for Use The BetaCone is intended for non-cemented use to replace th…
Centerpulse Orthopedics, Inc.20031

Also cleared against K930963: 2 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 18 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K930963.

How does its category compare?

All LWJ devices

LWJ 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

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

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

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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
20072—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

What is it indicated for?

The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:

• Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;

* Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and

* Revision of a previously failed hip arthroplasty.

Indications for use as stated in the FDA summary.

Also cleared against K930963

2 other devices cite the same predicate.

  • K962101Zweymueller SL Femoral Hip StemIntermedics Orthopedics · 1996
  • K955563Foundation Forged, Textured & Porous Stems W/Biolox Ceramic HeadsEncore Orthopedics, Inc. · 1996

More from Waldemar Link GmbH & Co. KG

43 FDA decisions under this applicant name. See the company

  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
  • K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG · 2025
  • K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
  • K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023

Recent decisions in LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007

https://510kreport.com/device/K051826 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051826: Betacone Hip Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051826

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