510(k) · Cleared
ClearedBethaLoc® stem cementless HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 20, 2023 as substantially equivalent to K203420 (Implantcast GmbH, 2021) and 6 other predicates after a 263-day review. Its family tree reaches back 14 generations to 1994. 1 later device descends from it.
- Decided
- Jun 20, 2023
- Review
- 263 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K931641 (1994). 325 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- 2 generations backK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- 1 generation backK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- This deviceK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Show all 14 generations
- Root · 14 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 12 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 11 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 10 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 9 generations backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- 8 generations backK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- 7 generations backK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- 6 generations backK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- 5 generations backK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- 4 generations backK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- 3 generations backK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- 2 generations backK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- 1 generation backK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- This deviceK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −12 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −11 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −10 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −9 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| −8 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| −7 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| −6 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| −5 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| −4 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| −3 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| −2 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| −1 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| 0 (this device) | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 4 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 31 | 0 |
| 1995 | 23 | 0 |
| 1996 | 26 | 0 |
| 1997 | 15 | 0 |
| 1998 | 16 | 0 |
| 1999 | 16 | 0 |
| 2000 | 28 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 13 | 0 |
| 2004 | 9 | 0 |
| 2005 | 13 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 |
|---|---|---|---|
| * | K203420 | EcoFit® Hip SystemSummary page 7…e used with previously cleared EcoFit® Hip components. Predicate Devices: Primary Predicate: • EcoFit® Hip System (K203420 K163577, K180263, and K191569) Reference Devices:… | 2021 |
| * | K163577 | Ecofit® Hip SystemSummary page 7…ith previously cleared EcoFit® Hip components. Predicate Devices: Primary Predicate: • EcoFit® Hip System (K203420 K163577, K180263, and K191569) Reference Devices: • Smith… | 2017 |
| * | K180263 | EcoFit Vit E Acetabular SystemSummary page 7…previously cleared EcoFit® Hip components. Predicate Devices: Primary Predicate: • EcoFit® Hip System (K203420 K163577, K180263, and K191569) Reference Devices: • Smith & Nephew,… | 2018 |
| * | K191569 | Implantcast ic-Bipolar Head SystemSummary page 7…® Hip components. Predicate Devices: Primary Predicate: • EcoFit® Hip System (K203420 K163577, K180263, and K191569) Reference Devices: • Smith & Nephew, Inc. SL-PLUS™ MIA Femoral… | 2019 |
| * | K122296 | SL-Plus Mia Femoral Stems with TI/HA CoatingSummary page 7…• Smith & Nephew, Inc. SL-PLUS™ MIA Femoral Stem with Ti/HA and SL-PLUS™ Femoral Stem with Ti/HA (K122296 and K143096) • Encore Medical TaperFill™ Femoral Hip Stem (K130099) Subs… | 2012 |
| * | K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASummary page 7…• Smith & Nephew, Inc. SL-PLUS™ MIA Femoral Stem with Ti/HA and SL-PLUS™ Femoral Stem with Ti/HA (K122296 and K143096) • Encore Medical TaperFill™ Femoral Hip Stem (K130099) Substantial… | 2015 |
| * | K130099 | Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019Summary page 7…Stem with Ti/HA (K122296 and K143096) • Encore Medical TaperFill™ Femoral Hip Stem (K130099) Substantial The BethaLoc® hip stems are substantially equivalent to the Equivalence: hip stems of the lega… | 2013 |
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 |
|---|---|---|---|
| K260037 | implantcast Packaging System Update | 2026 | 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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 65 of the 324 ancestors have a recall of any class.
- Of its descendants, K260037 (Implantcast GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K203420.
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. 2023, 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?
The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and • Revision of previously failed total hip arthroplasty. The EcoFit®, implaFit® and…
Read the full statement (225 words)
The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
• Revision of previously failed total hip arthroplasty.
The EcoFit®, implaFit® and BethaLoc® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation.
The implaFit® hip stems cemented are intended for cemented fixation.
The ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the BethaLoc® hip stems and EcoFit® Hip System for the following indications:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223103: BethaLoc® stem cementless HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223103
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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